Ercp: The Fundamentals [3 ed.] 1119601096, 9781119601098

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ERCP The Fundamentals

ERCP The Fundamentals

Third Edition Edited by

Peter B. Cotton, MD, FRCP, FRCS Digestive Disease Center Medical University of South Carolina Charleston, SC, USA

Joseph W. Leung, MD, FRCP, FACP, MACG, FASGE Department of Gastroenterology and Hepatology University of California Davis School of Medicine Sacramento, CA, USA; Section of Gastroenterology VA Northern California Health Care System GI Unit, Sacramento VAMC Mather, CA, USA

This edition first published 2020 © 2020 John Wiley & Sons Ltd Edition History Wiley‐Blackwell (2e, 2015) All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions. The right of Peter B. Cotton and Joseph W. Leung, to be identified as the author(s) of the editorial material in this work has been asserted in accordance with law. Registered Office(s) John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial Office 9600 Garsington Road, Oxford, OX4 2DQ, UK For details of our global editorial offices, customer services, and more information about Wiley products visit us at www.wiley.com. Wiley also publishes its books in a variety of electronic formats and by print‐on‐demand. Some content that appears in standard print versions of this book may not be available in other formats. Limit of Liability/Disclaimer of Warranty The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/ or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Library of Congress Cataloging‐in‐Publication Data Names: Cotton, Peter B., editor. | Leung, J. W. C., editor. Title: ERCP : the fundamentals / [edited by] Peter B. Cotton, MD FRCP FRCS, Professor of Medicine, Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, Joseph W. Leung, MD FRCP FACP MACG FASGE, Mr. & Mrs. C.W. Law Professor of Medicine, Department of Gastroenterology and Hepatology, University of California, Davis School of Medicine, Chief, Section of Gastroenterology, VA Northern California Health Care System, GI Unit, Sacramento VAMC Mather, California. Description: Third edition. | Hoboken, NJ : Wiley-Blackwell, 2020. | Includes index. Identifiers: LCCN 2020010927 (print) | LCCN 2020010928 (ebook) | ISBN 9781119601098 (hardback) | ISBN 9781119601067 (adobe pdf) | ISBN 9781119601081 (epub) Subjects: LCSH: Endoscopic retrograde cholangiopancreatography. | Gastroscopy. Classification: LCC RC847.5.E53 A38 2020 (print) | LCC RC847.5.E53 (ebook) | DDC 616.36/07572–dc23 LC record available at https://lccn.loc.gov/2020010927 LC ebook record available at https://lccn.loc.gov/2020010928 Cover Design: Wiley Cover Image: Courtesy of Joseph W. Leung Set in 9.5/12.5pt STIXTwoText by SPi Global, Pondicherry, India 10  9  8  7  6  5  4  3  2  1

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Contents List of Contributors  ix Introduction: Developments in ERCP over 50 Years  xiii Section 1  Preparation  1 1 Training and Assessment of Competence (Preparing the Endoscopist)  3 Joseph W. Leung and Peter B. Cotton 2 Preparing the Facilities and Equipment  17 Joseph W. Leung and Andrew Yen 3 ERCP: The Team  29 Phyllis Malpas 4 Minimizing Duodenoscope Infections  39 Catherine Bauer 5 Patient Education and Consent  45 Peter B. Cotton 6 Risk Assessment and Reduction  49 Erin Forster and Joseph Romagnuolo 7 Sedation, Anesthesia, and Medications  67 John J. Vargo, II

vi

Contents

Section 2  Techniques  75   8 Standard Devices and Techniques  77 Joseph W. Leung   9 When Standard Cannulation Approaches Fail  131 Sundeep Lakhtakia and Shyam Varadarajulu 10 Intraductal Therapies  149 Zaheer Nabi and D. Nageshwar Reddy 11 Endoscopic Ampullectomy  165 Michael Bourke 12 The Radiology of ERCP  181 Stuart Ashley Roberts and Derrick Martin 13 ERCP Reporting and Documentation  199 Lars Aabakken Section 3  Clinical Applications  209 14 ERCP in Acute Cholangitis  211 Wei-Chih Liao and Hsiu-Po Wang 15 ERCP Peri-Cholecystectomy  223 Paul R. Tarnasky 16 Difficult Bile Duct Stones  243 Majid A. Almadi and Alan Barkun 17 Patients with Obscure Biliary Pain; Sphincter of Oddi Dysfunction  257 Peter B. Cotton 18 Benign Biliary Strictures  263 John T. Cunningham 19 The Role of ERCP in Pancreaticobiliary Malignancies  275 John G. Lee 20 ERCP in Acute and Recurrent Acute Pancreatitis  291 Robert A. Moran and Gregory A. Coté

Contents

21 Chronic Pancreatitis  305 Benjamin L. Bick, Evan L. Fogel, and Stuart Sherman 22 Role of ERCP in Complicated Pancreatitis  321 Todd H. Baron 23 ERCP in Children  333 Moises Guelrud and Andres Gelrud Section 4  Quality and Safety  357 24 Adverse Events: Definitions, Avoidance, and Management  359 Peter B. Cotton and B. Joseph Elmunzer 25 Ensuring Really Competent Practice  385 Peter B. Cotton Index  393

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ix

List of Contributors Lars Aabakken, MD, PhD, BC Professor of Medicine Chief of Gastrointestinal Endoscopy Oslo University Hospital, Rikshospitalet Oslo, Norway Majid A. Almadi, MB, BS, MSc, FRC Division of Gastroenterology King Khalid University Hospital King Saud University Riyadh, Saudi Arabia Alan Barkun, MD, CM, MSc, FRCPC Division of Gastroenterology Montreal General Hospital, McGill University Montreal, Quebec, Canada

Benjamin L. Bick, MD Indiana University School of Medicine Indianapolis, IN, USA Michael Bourke, MD, PhD Clinical Professor of Medicine University of Sydney Sydney; Director of Gastrointestinal Endoscopy Westmead Hospital Westmead, Australia Gregory A. Coté, MD, MS Professor of Medicine Medical University of South Carolina Charleston, SC, USA

Todd H. Baron, MD, FASGE Director of Advanced Therapeutic Endoscopy Professor of Medicine Division of Gastroenterology & Hepatology University of North Carolina Chapel Hill, NC, USA

Peter B. Cotton, MD, FRCP, FRCS Professor of Medicine Digestive Disease Center Medical University of South Carolina Charleston, SC, USA

Catherine Bauer, RNBS, MSN, MBA, CGRN, CFER Director of Digestive Health University of Virginia Medical Center Charlottesville, VA, USA; Society of Gastroenterology Nurses and Associate President 2018–2019

John T. Cunningham, MD Professor Emeritus of Medicine Section of Gastroenterology and Hepatology University of Arizona School of Medicine Tucson, AZ, USA

x

List of Contributors

B. Joseph Elmunzer, MD, MSc The Peter B. Cotton Endowed Chair in Endoscopic Innovation Professor of Medicine and Endoscopic Innovation Division or Gastroenterology and Hepatology Medical University of South Carolina Charleston, SC, USA Evan L. Fogel, MD Indiana University School of Medicine Indianapolis, IN, USA Erin Forster, MD, MPH Department of Medicine Division of Gastroenterology and Hepatology Medical University of South Carolina Charleston, SC, USA Andres Gelrud, MD, MMSc Gastro Health and Miami Cancer Institute Miami, FL, USA Moises Guelrud, MD Gastro Health and Miami Cancer Institute Miami, FL, USA Sundeep Lakhtakia, MD, DM Asian Institute of Gastroenterology Hyderabad, India John G. Lee, MD H. H. Chao Comprehensive Digestive Disease Center University of California at Irvine Medical Center, Irvine, CA, USA Joseph W. Leung, MD, FRCP, FACP, MACG, FASGE Emeritus Professor of Medicine Department of Gastroenterology and Hepatology University of California Davis School of Medicine Sacramento, CA; Chief of Gastroenterology Section of Gastroenterology

VA Northern California Health Care System GI Unit, Sacramento VAMC Mather, CA, USA Wei-Chih Liao, MD, PhD Associate Professor Department of Internal Medicine National Taiwan University Hospital National Taiwan University College of Medicine Taipei, Taiwan Phyllis Malpas, MA, RN, CGRN Digestive Disease Center Medical University of South Carolina Charleston, SC, USA Derrick Martin, FRCR, FRCP, Mb, CHb Radiology Department Wythenshawe Hospital Manchester, UK Robert A. Moran, MD Medical University of South Carolina Charleston, SC, USA Zaheer Nabi, MD, DNB Gastroenterology Consultant Gastroenterologist Asian Institute of Gastroenterology Hyderabad, India D. Nageshwar Reddy, MD, DM, DSc, FRCP Chairman and Chief of Gastroenterology Asian Institute of Gastroenterology Hyderabad, India Stuart Ashley Roberts, MD Radiology Department University Hospital of Wales Cardiff, UK Joseph Romagnuolo, MD, MSc, FRCPC Department of Medicine Division of Gastroenterology and Hepatology Medical University of South Carolina Charleston, SC, USA

List of Contributors

Stuart Sherman, MD Indiana University School of Medicine Indianapolis, IN, USA Paul R. Tarnasky, MD Digestive Health Associates of Texas Program Director Gastroenterology Methodist Dallas Medical Center Dallas, TX, USA Shyam Varadarajulu, MD Center for Interventional Endoscopy Florida Hospital Orlando, FL, USA John J. Vargo, II, MD, MPH Cleveland Clinic Cleveland, OH, USA

Hsiu-Po Wang, MD Department of Internal Medicine National Taiwan University Hospital National Taiwan University College of Medicine Taipei, Taiwan Andrew Yen, MD, FACG, FASGE Chief of Endoscopy and Associate Chief of Gastroenterology Section of Gastroenterology VA Northern California Health Care System GI Unit, Sacramento VAMC Mather, CA, USA

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xiii

­Introduction: Developments in ERCP over 50 Years The History Attempts at endoscopic cannulation of the papilla of Vater were first reported in 1968. However, the method was put on the map shortly afterward by Japanese gastroenterologists working with instrument manufacturers to develop appropriate long side‐viewing instruments. The name “ERCP” (endoscopic retrograde cholangiopancreatography) was agreed at a symposium at the World Congress in Mexico City in 1974. The technique gradually became established worldwide as a valuable diagnostic technique, although some were skeptical about its feasibility and role, and the potential for serious complications soon became clear. It was given a tremendous boost by the development of the therapeutic applications, notably biliary sphincterotomy in 1974 and biliary stenting 5 years later. It is difficult for most gastroenterologists today to imagine the diagnostic and therapeutic challenges of pancreatic and biliary medicine 50 years ago. There were no scans. The pancreas was a black box and its diseases diagnosed only at a late stage. Biliary obstruction was diagnosed and treated surgically with substantial operative mortality. The period of 20 or so years from the mid‐1970s was a “golden age” for ERCP. Despite significant risks, it was quite obvious to everyone that ERCP management of bile duct stones, strictures, and leaks was easier, cheaper, and safer than available surgical alternatives. Percutaneous transhepatic cholangiography (PTC) and its drainage applications were also developed during this time but were used (with the exception of a few units) only when ERCP failed or was not available. The situation has evolved progressively in many ways during recent decades. There are some new techniques (such as expandable and biodegradable stents, simpler cholangioscopy, balloon sphincteroplasty, pseudocyst debridement, and laparoscopic‐ and endoscopic ultrasound [EUS]‐guided cannulation) and improvements in safety (e.g. pancreatic stents, nonsteroidal anti‐inflammatory drugs [NSAIDs], anesthesia, and carbon dioxide [CO2]). Other important changes in ERCP practice have been driven by improvements in radiology and surgery and the increasing focus on quality.

Radiology Imaging modalities for the biliary tree and pancreas have proliferated. High‐quality ultrasound, computed tomography (CT), EUS, and magnetic resonance scanning (with magnetic

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­Introduction: Developments in ERCP over 50 Year

resonance cholangiopancreatography [MRCP]) have greatly facilitated the noninvasive ­evaluation of patients with known and suspected biliary and pancreatic disease. As a result, ERCP is now almost exclusively used for treatment of conditions already documented by less‐invasive techniques. There have also been some improvements in interventional radiology techniques in the biliary tree, which are useful adjuncts when ERCP is unsuccessful or impractical.

Surgery There has been substantial and progressive reduction in the risks associated with surgery as a result of minimally invasive techniques and better perioperative and anesthesia care. It is no longer correct to assume that ERCP is always safer than surgery. Surgery should be considered as a legitimate alternative to ERCP and not only when ERCP is unsuccessful.

Patient Empowerment Another relevant development in this field is the increased participation of patients in decisions about their care. Patients are right in demanding information about their potential interventionists and the likely benefits, risks, and limitations of all of the possible approaches to their problems.

The Quality Imperative The term ERCP is now inaccurate. It was invented to describe a method for obtaining radiographs of the biliary and pancreatic trees. It is now a broad therapeutic platform, like laparoscopy. It may be better remodeled as “Ensuring Really Competent Practice,” because quality is now the main challenge. We have to make sure that the right things are done and in the right way. There is increasing attention on who should be trained and to what level of expertise. How many ERCPists are really needed? Previously, most gastroenterology trainees did some ERCP and continued to dabble in practice. Now the focus is on ensuring that there is a smaller cadre of properly trained ERCPists with sufficient numbers to maintain and enhance their skills and to be able to address the more complex cases. These issues come into clearest focus where the role of ERCP is still not firmly established (e.g. in the management of recurrent acute and chronic pancreatitis and of possible sphincter of Oddi dysfunction). Such issues are being addressed by increasingly stringent research.

This Book This is the third edition of this book devoted to ERCP. The first, Advanced Digestive Endoscopy: ERCP was published on gastrohep.com in 2002 and printed by Blackwell in 2006 and again in 2015. This edition owes much to its predecessors, but the title ERCP: The Fundamentals emphasizes our attempt to provide core information for trainees and practitioners, rather than a scholarly review of the (now) massive literature. Note that we have

­Introduction: Developments in ERCP over 50 Year

largely separated the technical aspects (how it can be done) from the clinical aspects, to allow the authors of the latter chapters to review the complex questions of when they might be done (and when best not). We greatly appreciate the efforts of all the contributors and look forward to constructive feedback. Peter B. Cotton, MD, FRCS, FRCP Joseph W. Leung, MD, FRCP, FACP, MACG, FASGE April 2020

xv

1

Section 1 Preparation

3

1 Training and Assessment of Competence (Preparing the Endoscopist) Joseph W. Leung1,2 and Peter B. Cotton3 1 

Department of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, CA, USA  Section of Gastroenterology, VA Northern California Health Care System, Sacramento VAMC, Mather, CA, USA 3  Digestive Disease Center, Medical University of South Carolina, Charleston, SC, USA 2

Key Points ●● ●● ●● ●●

ERCP includes a range of mainly therapeutic procedures of different levels of complexity. Training involves both clinical and technical aspects. Hands-on apprenticeship dominates, but various simulators can help. Competence should be assessed objectively, and the data made available to patients.

B ­ ackground ERCP is the most complex common endoscopic (digestive) procedure. It has great potential for benefit, but it also carries significant risk of failure, adverse events [1], and medicolegal jeopardy [2]. Clearly it must be done as well as possible, and there has been more focus on quality recently. The key questions are: ●● ●● ●● ●● ●●

Who should be trained? What should be taught, and how? Who should teach? How are training and competence assessed? What level of performance is acceptable?

­Who Should Be Trained? ERCP training is usually a part of the postgraduate training of selected gastroenterologists and a few surgeons. The number needed has fallen with the widespread use of magnetic resonance cholangiopancreatography (MRCP) (and also endoscopic ultrasound [EUS]). In the structured British National Health System, the number of training positions is now ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

4

ERCP: The Fundamentals

tailored to the projected population needs. In many countries, and especially in the United States, there is no such limitation, with the result that some trainees are short‐changed, and some have marginal volumes in ongoing practice. It is incumbent on training programs to ensure that those they train are able to reach an acceptable level of competence for safe independent practice. To limit training to less but produce more qualified trainees in the United States, some gastrointestinal (GI) programs have limited advanced endoscopy (ERCP and EUS) to a 4th year of training.

­What Should Be Taught, and How? While we focus here mainly on the difficulties involved in teaching the necessary technical skills, it is essential to realize that optimal ERCP requires that practitioners are knowledgeable about pancreatic and biliary medicine and the many alternative diagnostic and therapeutic approaches, as well as being skilled in the basic tenets of patient care. These important aspects should be well covered in basic GI training programs, such as the three‐year fellowships in United States. Hands‐on training is an integral part of ERCP practice and is done under close supervision by the trainer in a progressive manner to avoid mistakes that can be detrimental or may have a negative impact on outcome.

Levels of Complexity ERCP is not a single procedure. The term encompasses a large spectrum of interventions performed (mainly) through the papilla. The concept of levels of complexity or difficulty, introduced by Schutz and Abbot, has recently been updated by a working party of American Society for Gastrointestinal Endoscopy (ASGE) [3]. (Table  1.1). Levels 1 and 2 together include the standard (mostly biliary) procedures, which are needed at relatively short notice at the community level. The more complex level 3 (“advanced”) and 4 (“tertiary”) procedures are mainly performed by relatively few highly trained endoscopists in referral centers. These distinctions are clearly relevant to training. No one should be trained to less than competence at level 2. Although some practitioners will gradually advance those skills in practice (with mentoring, self‐study, and courses), there are increasing numbers of advanced positions (e.g. 4th year in the United States), providing training in the more complex procedures.

Progressive Training Like other endoscopy procedures, basic ERCP training involves lectures, study courses, didactic teaching, and the use of books, atlases, and videos in addition to hands‐on supervised clinical practice [4–6]. Clinical teaching includes the elements of a proper history and physical examination with pertinent laboratory tests. Overall management will include work with in‐ and outpatients with pancreaticobiliary problems, with discussion on the various diagnostic and treatment options, and the assessment and mitigation of risk. This

1  Training and Assessment of Competence (Preparing the Endoscopist)

Table 1.1  Complexity levels in ERCP. Basic, levels 1 and 2 Deep cannulation of duct of interest and sampling Biliary stent removal or exchange Biliary stone extraction 10 mm Minor papilla cannulation and therapy Removal of internally migrated biliary stents Intraductal imaging, biopsy, and needle aspiration Management of acute or recurrent pancreatitis Treat pancreatic strictures Remove pancreatic stones mobile and 5 mm Intrahepatic stones Pseudocyst drainage and necrosectomy Ampullectomy Whipple, Roux‐en‐Y, or bariatric surgery Adapted from Cotton et al [3]. EHL, electrohydraulic lithotripsy; PDT, photodynamic therapy.

is best achieved in a multidisciplinary environment, with close cooperation particularly with surgeons and radiologists. After a period of observation, technical training begins with learning the proper technique of scope insertion and positioning. Despite that trainees may have performed many upper endoscopy and colonoscopy procedures, handling and manipulating a side‐viewing duodenoscope requires a different skill set. It takes 20 to 30 cases before the novice endoscopist can master the basic skills of handling the side‐viewing scope. Selective cannulation of the desired duct (usually initially the bile duct) is the key challenge in ERCP because it is essential for therapeutic interventions. Incompetence in this aspect causes failure and increases the risk of postprocedural pancreatitis. Deep cannulation allows passage of guidewires to support sphincterotomy, stenting, and balloon dilation. Training in these basic steps should be delivered in stages. The trainer demonstrates the

5

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ERCP: The Fundamentals

technique and then gives verbal instructions to guide the hands‐on trainee. In difficult cases, the trainer may take over part of the procedure to complete the more difficult steps and then allow the trainee to continue. The trainees will acquire basic ERCP experience by learning the different steps, although not necessarily in a systematic manner. However, the trainee will be able to assimilate the experience and eventually be able to complete the entire procedure independently. The extent to which a trainee can learn more complex skills will depend on many factors, not least the length of time available and the case mix in the training center. It is also important for trainees to learn about all of the equipment that can be used during ERCP, including important aspects of radiology safety. In most centers, there may not be a dedicated radiology technician to assist with the operation of the fluoroscopy unit (usually a portable C‐arm). The trainee should receive appropriate training and certification to operate the fluoroscopy unit to ensure patient safety. Similarly, the correct interpretation of X‐rays is crucial to determine the next step in therapeutic intervention, and trainees should receive teaching in image interpretation to guide subsequent therapy. ERCP is a team event, and it is necessary to appreciate the importance of well‐trained and motivated staff.

Simulation Training The relative shortage of cases in many institutions and the risks involved in training have naturally encouraged the development of adjunctive alternatives to hands‐on experience. Simulation practice provides trainees an opportunity to handle the scope and accessories and get familiar with the procedure before performing on patients. Preliminary data indicates that simulation practice can improve the clinical performance of novice trainee ERCPists [5]. In recent years, credentialing and governing bodies have recommended or mandated the use of simulation in training as part of residency education, and simulators have been used extensively in surgery. The essence of simulation in ERCP training is to provide trainees with the opportunities to understand the basic anatomy, become familiar with the equipment (accessories), and learn the basic techniques of scope handling, manipulation of accessories, and coordination with the assistant without involving a patient. Unless the alternative practice method offers the opportunity to use a real scope and accessories with hands‐on experience, trainees may not be able to reap the benefits of additional or supplemental training. Different simulators are available for learning and practicing ERCP technique. Therefore, the IDEAL simulator/simulation training should provide trainees with the learning opportunity to Improve their basic skills, Demonstrates realism to help trainees understand the anatomy and motility, Ease of incorporating into a training program (i.e. inexpensive and portable system that allows repeated practices without special setup), Application in training including teaching therapeutic procedures, and Learning with real scope and accessories including use of simulation fluoroscopy [7]. Although ERCP practice on a live anesthetized pig offers the closest resemblance to the human setting, it is rarely used because it is expensive, labor‐intensive, difficult to organize without special facilities, and carries potential ethical concerns. In general, three types of

1  Training and Assessment of Competence (Preparing the Endoscopist)

simulators are available: computer simulators, ex‐vivo porcine stomach models, and mechanical simulators (Table 1.2). Computer simulators (e.g. GI Mentor II) are useful for learning the anatomy, including duodenal motility and basic orientation for cannulation [8]. However, the computer simulator uses special probes instead of real accessories, and this lacks realism and does not offer the tactile sensation when it comes to the manipulation of the “scope and accessories” for therapeutic ERCP. A more commonly used training model is the ex‐vivo porcine stomach model with attached biliary system that allows trainees to practice with a real scope and accessories [9]. However, the anatomical variation (i.e. close proximity of the papilla to the pylorus in the porcine model) makes scope positioning and cannulation more difficult. Besides, there are separate biliary and pancreatic ductal openings, making it suboptimal to practice selective cannulation. To facilitate the practice of biliary papillotomy, the porcine model is further improved by attaching a chicken heart (Neopapilla model) to a separate opening created in the second portion of the duodenum, which corrects for the anatomical difference and allows multiple (up to three) papillotomy practices to be performed on each chicken heart (artificial papilla) [10]. Another form of supplemental simulation training involves the use of mechanical ­simulators, namely the ERCP mechanical simulator (EMS) or the X‐vision ERCP simulator [11, 12]. Both use a rigid model with special papillae adapted to a mechanical duodenum. Selective cannulation can be achieved using injection of a color solution (X‐vision) or using a guidewire with the help of a catheter or papillotome (EMS). The X‐vision model allows practice papillotomy to be performed on artificial papillae made of a special molded material [13]. The EMS allows practice papillotomy using a foamy papilla soaked with a special conducting gel [14]. In addition, dilation of stricture, brush cytology, and stenting as well as basket stone extraction and mechanical lithotripsy can be performed using the EMS. There are also mechanical models used by equipment companies for practicing special accessories, but no data are reported in the literature. Despite different simulators being available to supplement clinical ERCP training, and two prospective trials showing their value in improving the basic skills of trainees [15, 16], their use has been largely restricted so far to special teaching workshops. As part of teaching workshops, trainees and trainers were asked to evaluate the different simulators available for learning ERCP. A head‐to‐head comparison was conducted between the EMS and computer simulator and another one compared the EMS and modified pig stomach model (PSM) in terms of their ease and efficacy for ERCP practice. The EMS and PSM were both considered useful for ERCP practice because they used a real scope and accessories [17]. The EMS was rated better than the computer simulator for the same reason [18].

­Who Should Teach? A skilled endoscopist may not necessarily be a good teacher. The trainer needs to be able to recognize and correct the errors (mistakes) made by the trainee both in terms of technical operation and in clinical judgment and to do it in a supportive and nonpunitive manner. The “Train the trainer” courses have been beneficial in highlighting the key elements. In the British system, attendance at such courses is now mandated, and trainees are required to assess their teachers in the e‐portfolio system.

7

Table 1.2  A comparison of different simulator models for advanced ERCP training. Mechanical Simulator

Computer Simulator

EMS and X-vision

GI Mentor II

Live animal

Ex-vivo porcine stomach model

References

7, 11, 13–17

8

5

9,10

Preprogrammed

No

Yes

No

No

Demonstrates anatomy

Simulated

Simulated

Yes*

Yes*

Demonstrates motility

No

Simulated

Yes

No

Basic equipment

Scope and diathermy

Probes and software

Scope and diathermy

Scope and diathermy

Real scope and accessories

Yes

No Modified probes

Yes

Yes

Papillotomy

Yes (artificial)

Simulated

Yes

Yes (Neopapilla‡)

Animal Tissue Model

Learning experience

Tactile sensation

Very good

Good

Very good

Very good

Coordination/teamwork

Yes

Maybe

Yes

Yes

Supervised training

Yes

Maybe

Yes

Yes

Scoring of experience

Yes (manual)

Yes (computerized)

Yes (manual)

Yes (manual)

Maybe

Maybe

Maybe

Clinical benefits

†

Yes (EMS )

Technical support

Anesthesia/technician

No/No

No/No

Yes/Yes

No/Yes

Assistant

Yes

No

Yes

Yes

Fluoroscopy (+timer)

Simulated No

Yes

Trans‐illumination

Estimated cost of model

$3–5K

$1K/animal

$90K

$250/set §

Repeated practice

Yes

Yes

Yes (same day)

Yes (same day)§

Special/animal lab dedicated scope

No

No

Yes

Yes

Varying level of difficulties

Yes

Yes (programmed) No

No

Objective assessment

Yes

Computer report

Yes

Yes

Documentation

Manual

Computerized

Manual

Manual

Reproducibility

Yes

Yes

Maybe

Maybe

Part of routine training

Easy

Easy

Difficult

Maybe

EMS, ERCP mechanical simulator; RCTs, randomized controlled trials. * Anatomical variation with pig stomach model; the papilla is close to the pylorus. †  EMS is only model with two published RCTs and one abstract with results showing improvement of trainees’ clinical performance with coached simulation practice. ‡  Neopapilla modification allows for multiple papillotomy practices (up to three per “papilla”). §  Live‐animal model allows for only one papillotomy per animal. Ex‐vivo model allows for only one papillotomy unless modified using the Neopapilla.

1  Training and Assessment of Competence (Preparing the Endoscopist)

­How Are Training and Competence Assessed? Whatever training methods are employed, the key issue clearly is how well the trainee can perform. Trainees should keep logs of their procedures (on simulators as well as patients), and some metrics are suggested in Tables 1.3, 1.4, and 1.5. Table 1.3  Some suggested simulator practice score to evaluate trainees’ practice performance. Cannulation Position—Achieve proper orientation and axis

1

Failed cannulation

Successful/deep cannulation of selected system

1

Number of attempts

–2

Manipulate wire for cannulation and stricture

1

Loss wire or access

–1

Coordinated exchange of accessories

1

End of wire on floor

–1

Proper preparation of insufflator

1

Excess air left in balloon

–1

Maintain position of balloon during dilation

1

Stent too short or too long

–2

Stone pushed into IHBD

–1

Deviated cut

–2

Hands‐on assistance 25%

–1

50%

–2

75%

–3

Wire manipulation

Balloon dilation

Cytology Control position of brush during cytology

1

Document bare brush across stricture

1

Stenting Able to measure stent length properly

1

Proper deployment of stent

1

Deploy multiple stents in common duct

1

Demonstrates how to deploy SEMS

1

Basket Proper stone engagement and removal

1

Demonstrate how to free impacted basket and stone

1

Demonstrate skill with use of mechanical lithotripter

1

Retrieval balloons Able to control balloon size

1

Papillotomy Maintain good position during cut

1

Control tension on cutting wire

1

Shaping wire position if indicated

1

Perform stepwise cut

1

Sizing the papillotomy

1

Assistance from trainer Verbal instructions only

1

IHBD, intrahepatic bile duct; SEMS, self‐expandable metallic stent.

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ERCP: The Fundamentals

Table 1.4  Clinical assessment (to be filled in by trainer at completion of ERCP). ERCP performance score Trainee performed procedures without trainer’s hands‐on assistance Selective cannulation

yes

no

NA

Biliary sphincterotomy

yes

no

NA

Pancreatic sphincterotomy

yes

no

NA

Biliary stone extraction

yes

no

NA

Balloon dilation

yes

no

NA

Brush cytology

yes

no

NA

Biliary plastic stent

yes

no

NA

Pancreatic plastic stent

yes

no

NA

Metal stent placement

yes

no

NA

Mechanical lithotripsy

yes

no

NA

(yes = 1, no = 0; actual ERCP performance score = sum/number of applicable categories, the score is used as a covariable for analysis)

ERCP “error” score Did the following occur during this trainee performed ERCP? Failed cannulation

yes

no

NA

Introduce air into ducts

yes

no

NA

Overfilled (obstructed) ductal system

yes

no

NA

End of guidewire on floor

yes

no

NA

Loss wire/access

yes

no

NA

Inappropriate length (too short) stent used

yes

no

NA

Failed to document bare brush across stricture

yes

no

NA

Uncontrolled papillotomy cut

yes

no

NA

Stone being pushed into IHBD

yes

no

NA

Stone and basket impaction

yes

no

NA

(yes = 0, no = 1; actual ERCP “error” score = sum/number of applicable categories; this score is used as a covariable for analysis).

Clinical performance assessment (excellent, good, poor, not assessed) Preparation of the patient before the procedure Care after the procedure Assessment of prior imaging Interpretation of ERCP radiographs Communication with the patient with the family with referrers Overall assessment of current competence in standard ERCP skills (%): IHBD, intrahepatic bile duct.

1  Training and Assessment of Competence (Preparing the Endoscopist)

Table 1.5  Trainer assessment score of trainees’ performance (five-point score). 5. (Excellent) Demonstrates good knowledge in operating the accessories, able to successfully complete procedure in >80% of cases, no iatrogenic‐induced failure or complication, or performance as good as an attending 4. (Good) Demonstrates good knowledge, good skills, needs only occasional assistance from trainer 3. (Average) Understands the operation of accessories, demonstrates only reasonable knowledge in actual operation of accessory, average skills, requires assistance from trainer 2. (Fair) Can handle the side‐viewing duodenoscope, understands the operation of accessories, unsure about actual operation or performance of accessories, requires >50% help from trainer 1. (Poor) Good control of upper gastrointestinal (GI) scope, struggles with side‐viewing scope, some knowledge of accessories but does not understand the operation or control of accessories or wires, needs lot of attention and assistance from trainer

Objective assessment of performance is easier to document with practice on simulators (Table 1.2). Specific endpoints may include successful execution of the procedure and total procedure time taken, including the use of simulated fluoroscopy time during the practice [11]. Documentation during computer simulation training is more complete with tracking of the time taken and number of attempts made to perform a particular procedure. Adjustment or modification in training can be done by using different computer software programs with varying levels of complexity, whereas the mechanical simulator can incorporate different setup, including changing position of the papilla or level of the bile duct stricture. Such changes can cater for procedures with varying level of difficulties from basic cannulation to papillotomy and to the more advanced procedures such as multiple stents placement for a simulated bile duct stricture [19]. In general, trainer assessment is more subjective based on a summation of the overall clinical performance of the trainees (Tables 1.3 and 1.4), both technical and clinical. The Accreditation Council for Graduate Medical Education (ACGME) has devised objective endpoints for measuring the quality of ERCP training and success with the procedure, but strictly speaking, these endpoints cannot account for all of the different aspects of this technical procedure.

Numbers The question “How many hands‐on cases does a trainee need to become competent?” has dominated and confused the field for decades. The original guess by ASGE that 100 might be sufficient was shown to be seriously inadequate by the seminal study by Jowell et  al that showed that their trainees were only approaching 80% competency after 180–200 procedures [20]. The ASGE recommends that trainees should have performed 200 ERCP procedures with 80% success of cannulation and more than half of the procedures being therapeutic before they are considered competent or ready for assessment of competency [21]. Australia has an even tougher criterion, which requires trainees to have performed 200 successful solo procedures without trainer involvement [22]. These assessments are usually made by a sympathetic trainer at “home base” and are a complex amalgam of subjective information. We usually think that the trainee is “reasonably

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ERCP: The Fundamentals

OK,” but we do not know how they actually perform once in practice with less‐experienced staff (and maybe unfamiliar equipment) and with some peer pressure to succeed. The only important numbers (in practice and in training) are the actual outcomes, using agreed quality metrics, such as deep biliary cannulation success and pancreatitis rates. Thus, we have long recommended that practitioners collect these data (report cards) [23] and compare them with peers (benchmarking) [24]. These systems also include complexity levels, so that the spectrum of practice can be documented. Because of the need for X‐ray, ERCP is the one endoscopic procedure that is done only in hospitals. Hospitals have the responsibility for ensuring that their credentialing and privileging systems allow only competent endoscopists into their units. A survey of credentialing practice in the United States suggests that there is room for improvement [25]. How else can we move forward? The assessment at the end of training could be made by people other than their trainers by a combination of log books, videos, references, and observation of procedures (live and simulated) in their home environment or elsewhere. Ideally there should be some form of certification at a national level, incorporating the complexity levels.

­What Level of Performance Is Acceptable? There are significant variations in the quality of ERCP performance. Taking deep biliary cannulation as a key metric, we know that experts achieve greater than 95% success, but not all cases can or should be done by experts. So what is acceptable, and who decides? Professional societies have usually suggested 85% or 90% in general, but much depends on the clinical circumstances and setting. A less‐expert endoscopist will be acceptable and may be lifesaving, in an emergency (e.g., acute cholangitis), but patients with more complex and elective problems may prefer (if given the option) referral to a tertiary center. Patients should not be afraid to quiz their potential interventionists about their experience and ask to see the report card [23]. These aspects are discussed further in Chapter 25.

­Conclusion ERCP now constitutes a variety of procedures, which require excellent clinical and technical skills with an experienced team in a supportive environment. The structures of training and practice are gradually being improved so as to raise the quality of ERCP practice worldwide, and patients are increasingly knowledgeable about the issues. We hope to see fewer, poorly trained, low‐volume ERCPists in the future [26].

Appendix Some examples of how to gauge trainees’ performance during clinical practice

1  Training and Assessment of Competence (Preparing the Endoscopist)

Cannulation Understanding the use of contrast (different concentrations), priming the catheter and eliminating air bubbles, preparing wire‐guided papillotome (and if necessary, shaping the catheter or papillotome) Able to achieve proper positioning with correct orientation and alignment with the axis of respective ducts for selective and deep cannulation of individual system (common bile duct [CBD] or pancreatic duct [PD]), appropriate use of contrast injection, avoid overfilling of pancreas or obstructed biliary systems, and able to capture good radiograph for documentation

Guidewire Manipulation Understanding the use of different guidewires and their application, able to manipulate guidewire with coordinated exchange of accessories, good control during exchange and avoid losing wire position, if necessary, able to shape tip of guidewire to negotiate difficult (angulated) bile duct stricture, selective placement of guidewire into right and left intrahepatic system or pancreatic duct

Dilation (Rigid or Balloon) Understanding the use of rigid catheter dilator compared with pneumatic balloons, understand how to fill insufflator with (dilute) contrast and eliminate air in syringe and operate insufflator, choice of balloon size, good coordination with exchange, and maintaining ­position of balloon during dilation Understand the use of Soehendra stent retriever for dilation in special circumstances

Cytology Understanding the use of double‐lumen cytology or single‐lumen cytology brush, choice of brush in different situations (biliary or pancreatic), able to control (and document) the position of the brush during taking a cytology specimen, understand how to prepare specimen slides and samples

Stenting Understand the difference between straight and double‐pigtail stents, choice of stents, know and demonstrate how to measure stent length using different methods, choice of guidewire for difficult stenting (intrahepatic bile duct [IHBD] stricture), special stent (for left hepatic duct [LHD]) and proper deployment of stent (position and length), and able to deploy multiple stents in common duct and right and left hepatic ducts

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ERCP: The Fundamentals

Basket Understand the operation of different types of baskets, wire‐guided basket, lithotripsy basket, understand and demonstrate proper stone engagement and removal, demonstrate how to free an impacted basket and stone, understand and demonstrate skill with use of mechanical lithotripter, understand and know how to steer the basket into intrahepatic system

Retrieval Balloons Understand how to operate a stone retrieval or occlusion balloon, know how to control the volume of air inflated into the balloon, avoid over inflating the balloon, and know how to adjust balloon size (using the two‐way stopcock) during course of action

Papillotomy Understand the axis of the bile duct and pancreatic duct, know how to perform a controlled cut along the respective axis, know how to correct a deviated cut and know when to stop cutting, demonstrate understanding and perform different hemostasis methods to control post‐papillotomy bleeding and able to insert biliary stent to ensure drainage

­References 1 Cotton PB. Complications of ERCP. In: Cotton and Leung, eds. Advanced Digestive Endoscopy: ERCP, 339–403. Malden, MA: Blackwell Publishing, 2005. 2 Cotton PB. Analysis of 59 ERCP lawsuits; mainly about indications. Gastrointest Endosc 2006;63:378–382. 3 Cotton P, Eisen G, Romagnuolo J, et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc 2011;73:868–874. 4 Cohen J. Training and credentialing in gastrointestinal endoscopy in endoscopy practice and safety. In: PB Cotton, ed. Advanced Endoscopy [e‐book], Gastrohep.com 2005: 1–50. 5 Leung J, Lim B. Training in ERCP. In: Cohen, ed. Successful Training in GI Endoscopy. Oxford: Wiley‐Blackwell, 2010;85–96. 6 Chutkan RK, Ahmad AS, Cohen J, et al. ERCP core curriculum. Gastrointest Endosc 2006;63(3):361–376. 7 Leung JW, Yen D. ERCP training—the potential role of simulation practice. J Interv Gastroenterol 2011;1:14–18. 8 Bar‐Meir S. Simbionix simulator. Gastrointest Endosc Clin N Am 2006;16(3):471–478, vii. 9 Neumann M, Mayer G, Ell C, et al. The Erlangen Endo‐Trainer: lifelike simulation for diagnostic and interventional endoscopic retrograde cholangiography. Endoscopy 2000;32:906–910.

1  Training and Assessment of Competence (Preparing the Endoscopist)

1 0 Matthes K, Cohen J. The neo‐papilla: a new modification of porcine ex‐vivo simulators for ERCP training (with videos). Gastrointest Endosc 2006;64(4):570–576. 11 Leung JW, Lee JG, Rojany M, et al. Development of a novel ercp mechanical simulator. Gastrointest Endosc 2007;65(7):1056–1062. 12 Frimberger E, von Dellus S, Rosch T, et al. A novel and practicable ercp training system with simulated fluoroscopy. Endoscopy 2008;40:517–520. 13 von Delius S, Thies P, Meining A, et al. Validation of the X‐Vision ERCP training system and technical challenges during early training of sphincterotomy. Clin Gastroenterol Hepatol 2009;7(4):389–396. 14 Leung J, Yen D, Lim B, et al. Didactic teaching and simulator practice improve trainees’ understanding and performance of biliary papillotomy. J Interv Gastroenterol 2013;3:51–55. 15 Lim B, Leung J, Lee J, et al. Effect of ERCP Mechanical Simulator (EMS) practice on trainees’ ERCP performance in the early learning period: U.S. multi‐center randomized controlled trial. Am J Gastroenterol 2011;106:300–306. 16 Liao W, Leung J, Wang H, et al. Coached practice using ERCP mechanical simulator improves trainees’ ERCP performance: a randomized controlled trial. Endoscopy 2013;45:799–805. 17 Leung J, Lim B, Ngo C, et al. A head‐to‐head comparison of practice with ERCP computer (ECS) and mechanical (EMS) simulators by experienced endoscopists and trainees. Dig Endosc 2012;24:175–181. 18 Leung J, Wang D, Hu B, et al. A head‐to‐head hands‐on comparison of ERCP mechanical simulator (EMS) and ex‐vivo porcine stomach model (PSM). J Intervent Gastroenterol 2011;1:108–113 19 Leung JW, Lee W, Wilson R, et al. Comparison of accessory performance using a novel ERCP mechanical simulator. Endoscopy 2008;40:983–988. 20 Jowell PS, Baillie J, Branch MS, et al. Quantitative assessment of procedural competence. a prospective study of training in endoscopic retrograde cholangio‐pancreatography. Ann Intern Med 1996;125(12):983–989. 21 Baron T, Petersen BT, Mergener K, et al. Quality indicators for endoscopic retrograde cholangiopancreatography. Gastrointest Endosc 2006;63(4):S29–S34. 22 Conjoint Committee for Recognition of Training in Gastrointestinal Endoscopy. Endoscopic Retrograde Cholangiopancreatography (ERCP). Available at: https://www. conjoint.org.au/applicants.php#ercp. Accessed December 27, 2019. 23 Cotton PB. How many times have you done this procedure, doctor? Am J Gastroenterol 2002;97:522–523. 24 Cotton PB, Romagnuolo J, Faigel DO, et al. The ERCP Quality Network: a pilot study of benchmarking practice and performance. Am J Medical Quality 2013;28(3):256–260. 25 Cotton PB, Feussner D, Dufault D, et al. A survey of credentialing for ERCP in the United States. Gastrointest Endosc 2017;86:866–869. 26 Cotton PB. Are low‐volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice‐NOW. Gastrointest Endosc 2011;74(1):161–166.

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2 Preparing the Facilities and Equipment Joseph W. Leung1,2 and Andrew Yen2 1 2

Department of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, CA, USA Section of Gastroenterology, VA, Northern California Health Care System, Sacramento VAMC, Mather, CA, USA

Key Points ●●

●●

●●

●●

●●

●●

An organized purposely designed room provides a functional floor plan with places for fixed equipment, work space for various staff, and ready access to accessories. The endoscopy and fluoroscopy display monitors should be placed side by side at eye level directly opposite to the endoscopist and assistant to facilitate ERCP procedures. A large 4.2-mm channel duodenoscope that accepts 10 Fr accessories is preferred for most procedures in adults. Understanding the setup and functions of diathermy units is crucial for a successful sphincterotomy. Close coordination between the endoscopist and assistant is necessary for exchanges with the long wire system. Endoscopists should be familiar with the advantages of using short guidewire systems.

ERCP is a team event with many contributing elements. The key issues for endoscopists, trainees, gastrointestinal (GI) assistants, anesthesia, radiology, and reporting are covered in separate chapters. This chapter addresses the physical facilities and equipment.

­Room Setup and Floor Plan Having a room dedicated to ERCP is ideal, but ERCPists and centers with relatively low volumes often have to share space with radiology. Apart from issues of scheduling, there are several reasons why that arrangement may be problematic. The room may be too small to accommodate comfortably all the equipment and personnel (including anesthesia when needed). The layout may expose team members to more radiation than is ideal. Another important issue is the position of the monitors. ERCPists need to have the fluoroscopy and endoscopy monitors side by side, which may be difficult to arrange. Additionally, it is ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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ERCP: The Fundamentals

tedious and inefficient to transport all of the potentially needed equipment for each case. The same issues arise when ERCP is done in other places, such as operating rooms and intensive care units. The principle design features of a dedicated ERCP room and the main items of equipment are described herein. The ERCP room should be large enough (at least 450 square feet) to house all the endoscopy equipment, monitors, anesthetic equipment, in addition to the fluoroscopy unit and the staff. The space should be allocated into convenient functional areas for the many people who may be involved (i.e. the endoscopist[s] GI nurse/assistant[s], radiology tech, sedation/anesthesia staff, plus any trainees and observers [Figure 2.1]). Accessories should be organized and stored to facilitate easy retrieval during procedures (Figure 2.2). Detail of the fluoroscopy equipment is described in (Chapter 12), but essentially a portable C‐arm fluoroscopy unit is sufficient for ERCP. It should be equipped with a foot pedal control for screening and ideally have another foot control for image capture. Manual or remote image capture by handheld device will require additional assistant support. A printing facility is preferable for making hard copies for subsequent review, although most units now have the capability of recording or importing images to either a server or endoscopy computer program. The fluoroscopy bed should preferably have an electrical (hand‐operated) control that allows a four‐way movement of the fluoroscopy bed for proper positioning of the image

Monitors X-ray monitor

X-ray

Endoscopes

C-arm VCR Vital signs S Foot controls E

Storage

Diathermy Fluoro

A

Scope tower

Worktop

Figure 2.1  Room set-up and floor plan. A, assistant; E, endoscopist; S, sedationist.

2  Preparing the Facilities and Equipment

Figure 2.2  Space for endoscopists and trainee or assistant. Accessories organized and are within easy reach of endoscopist.

display on the monitor. A hand‐operated mechanical control will serve as an alternative. For staff protection, additional lead aprons or shields should be hung around the bed (for fluoroscopy units with an under‐couch tube), and additional lead shield is placed on the bed to protect the (reproductive organs of) patients who are young or female. The spacer (that kept a distance between the X‐ray tube and the patient) should always be used to avoid (excess) radiation injury to the patient. The endoscopy and fluoroscopy monitors should be placed side by side. (Figure 2.3) (or combined on a large screen) and ceiling‐mounted at eye level across the X‐ray table (usually to the right behind the patient’s head) for the convenience of both the endoscopist and the key assistant. Some units have the endoscopy monitor mounted on the endoscopy cart placed by the head of the patient. This setup requires the endoscopist to turn more to the right and away from the patient, which can predispose the endoscopist to displace the scope or strain the endoscopist’s back and neck. If the fluoroscopy monitor cannot be moved (as in some older machines), it may be necessary to tap the signal and display it on another monitor placed together with the endoscopy monitor.

­Modern Design of the ERCP Room There is increasing interest to perform ERCP in combination with endoscopic ultrasound (EUS) examination during the same session, especially in patients with suspected pancreaticobiliary diseases to obtain tissue diagnosis and to provide drainage with stenting. It may

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ERCP: The Fundamentals

Figure 2.3  Monitors for endoscopy, fluoroscopy, and vital signs are placed together at eye level.

be necessary to design a bigger room to accommodate both EUS and ERCP equipment. In specialized centers where there is a strong collaboration between endoscopists and GI surgeons, the ERCP room design may resemble a hybrid operating room where combined laparoscopic and endoscopic surgery can be performed for patients with biliary diseases (e.g. prelaparoscopic cholecystectomy clearance of common bile duct [CBD] stones). In referral centers that manage large number of patients with chronic pancreatitis and large calcified stones, having additional special setup, including an extracorporeal shock wave lithotripsy (ESWL) machine (in a separate room) for stone fragmentation, may facilitate the management of patients with pancreatic stones.

The Endoscopy Tower/Support System The endoscopy support system includes the light source, video processor, and recording equipment. This is all best mounted on a boom suspended from the ceiling (which avoids having wires trailing across the floor). Alternatively, a purpose‐designed cart can be used. The position of this equipment can be adjusted to the preference of the endoscopist and is usually placed to the right of the endoscopist, with sufficient room left in between for the assistant to manipulate accessories (Figure 2.4a). Although the boom support minimizes the problem of having cables on the floor as opposed to using endoscopy cart(s), the booms are mounted and suspended from the ceiling, and the positioning of these booms can be challenging because of the restricted angle of movement from the pivot. They should ideally be properly set up and remain in a fixed position to facilitate operation (Figure 2.4b).

2  Preparing the Facilities and Equipment (a)

(b)

Figure 2.4  (a) Layout of ERCP room with endoscopy tower and foot pedals, monitors, fluoroscopy bed, and anesthetic equipment. (b) Layout of ERCP room with the use of booms to support the endoscopy equipment, ceiling-mounted monitors, and anesthetic equipment.

Duodenoscopes Video endoscopes are available from several manufacturers, namely Olympus, Pentax, and Fujinon. The larger “therapeutic” endoscopes with a 4.2‐mm channel are preferred for most procedures in adults because it can accept the large 10 Fr accessories. The smaller endoscope with a 3.2‐mm channel can be used when luminal narrowing is expected and in children older than the age of 2. Smaller pediatric duodenoscopes (with a 2.0‐mm channel) are available for examination in neonates. In patients with a distorted anatomy or postsurgical changes, it may be necessary to use a forward‐viewing scope such as the pediatric colonoscope for Billroth II gastrectomy or an enteroscope for patients with Roux‐en‐Y hepaticojejunostomy. An upper GI endoscope can sometimes be used to traverse a prior choledochoduodenostomy to access the intrahepatic ducts. The Spyglass system is a free‐standing unit that goes through the large channel scope and allows direct cholangioscopy to be performed by a single operator. Extra‐large channel endoscopes are available for insertion of the fiber‐optic “baby” choledochoscopes and pancreatoscopes. The newer digital cholangioscope can be inserted through the 4.2‐mm channel duodenoscope. The designs of the common duodenoscopes are broadly similar. The Olympus V‐system model incorporates a notch at the modified elevator (V‐notch) that allows the elevator to grip and hold steady the guidewire during exchange of accessories.

Gas Used for Examination In general, air insufflation is used to assist endoscopy procedures including ERCP. Minimal air should be used during intubation to avoid looping in the distended stomach. Excess gas insufflation can result in regurgitation of air into the stomach causing the patient to belch, which may transiently disrupt the procedure. Carbon dioxide (CO2) has been used in place

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ERCP: The Fundamentals

of air for insufflation, and a high flow may be necessary to maintain adequate distention of the duodenum during examination. Because CO2 is absorbed more quickly, postprocedural abdominal distension or discomfort during recovery can be reduced.

Accessories The commonly used ERCP accessories are listed in Table 2.1 and are discussed next. Other more complex or advanced accessories and their applications will be described individually in the chapter on techniques (Chapter 7). Cannulas/Catheters

These are simple long plastic tubes, usually of 5 Fr gauge, with a tapered or rounded radiopaque tip. They are used for injection of contrast and for insertion of guidewires. These functions can be done by exchange in a single channel, but catheters with two channels are easier to use. Similar catheters are used for aspiration of bile or fluids, irrigation, and insertion of cytology brushes. Sphincterotomes

Standard “pull‐type” sphincterotomes are plastic catheters with an exposed 2‐ to 3‐cm wire for coagulation and cutting. They also have one or two channels for injection and passage of guidewires. Traction on the cutting wire can facilitate selective cannulation by deflecting the tip. Shaping the tip of the papillotome sometimes allows more accurate positioning of the cutting wire and also better alignment with the bile duct axis to improve success of selective cannulation. The needle‐knife sphincterotome is a simple catheter with a central short extendable ­cutting wire. It can be used to cut open the papilla to obtain access to the bile duct when standard approaches fail (with or without an indwelling [pancreatic] stent) and to initiate drainage of a pseudocyst. Stone Extraction Balloons and Baskets

These are used for removing stones from the bile duct or pancreatic duct depending on the size and location of the stones and the exit passage (distal bile duct and sphincterotomy). Balloons can be used to perform an occlusion cholangiogram where contrast is injected under pressure with the inflated balloon preventing regurgitation of contrast. The inflated balloon can also be used to test the adequacy of a sphincterotomy or after dilation of bile duct strictures. Baskets typically have four wires arranged in a hexagonal configuration (Dormia basket). They are often used to engage and remove stone(s) in the bile duct. Those designed for lithotripsy or stone fragmentation have stronger wires and an outer metal sheath. Traction is applied to the basket wires using a crank handle to crush the stone against the metal sheath. Dilation Catheters and Balloons

These are used over guidewires to dilate strictures in the bile duct and pancreatic duct. The dilation catheters are stiff (often made of Teflon) with a tapered tip (a radiopaque maker denotes the point of maximum diameter).

2  Preparing the Facilities and Equipment

Table 2.1  Commonly used ERCP accessories. Item

Examples

Function

Catheter (S, LW)

Bullet tip (C), Taper tip (C), 5‐4‐3 (B)

Single channel for diagnostic injection of contrast and assists in passage of guidewire for selective cannulation (use with special adaptor)

Needle‐tip catheter (S)

Cramer (C)

For minor papilla cannulation (pancreas divisum)

Catheter (D, SW)

Fusion glow tip (C), RX (B)

Separate channel for contrast injection and passage of short guidewire (special design)

Sphincterotome (D, T), (LW, SW)

Cannulatome (C), DASH Papillotome (C), Clever cut (O) Truetome (B), Autotome (B)

Facilitate insertion of guidewire for selective cannulation; Biliary and pancreatic sphincterotomy

Precut sphincterotome (D, LW), (SW)

Needle‐knife, Huibregtse (C), Microknife (B)

Precut sphincterotomy for impacted stone or stent guided sphincterotomy and minor papilla sphincterotomy

Stone extraction basket (D, C)

22Q (O), Webb (C), Trapezoid (B)

Removal of biliary and pancreatic stones; (lithotripsy compatible)

Special basket

Flower (O)

Removal of small stones or stone fragments

Stone extraction balloon (D,T, A)

Escort (C), Fusion (C), Extractor RX(B), Extractor XL (B)

For occlusion cholangiogram; sizing of strictures and sphincterotomy; stone extraction; deflection of guidewire for selective cannulation of intrahepatic system

Cannulation

Sphincterotomy

Stone extraction

Special devices for stone extraction Lithotripsy basket

Fusion basket (C), Trapezoid (B)

Stone extraction with the option of lithotripsy if required

Lithotripter sheath

Soehendra Lithotripter (C)

For stone fragmentation in the event of unexpected stone and basket impaction

Mechanical lithotripter

BML (O)

Special basket with built‐in metal sheath and handle for fragmentation of large stones

Electrohydraulic

Walz

Intraductal lithotripsy using choledochoscopy

Laser

Holmium laser

Intraductal lithotripsy in combination with choledochoscopy

Cholangioscope

Mother & Baby scope (O), Spyglass (B)

Choledochoscopy to facilitate biopsy and intraductal therapy, including selective cannulation and intraductal lithotripsy

Dilation catheter (S)

Cotton/ Cunningham (C)

Dilation of tight biliary or pancreatic strictures

Dilation balloons (D, Con)

Quantum (C), Fusion Titan (C), Hurricane RX (B), Maxforce (B)

Dilation of biliary or pancreatic strictures; balloon sphincteroplasty

Stricture dilation

(Continued)

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ERCP: The Fundamentals

Table 2.1  (Continued) Item

Examples

Function

Cytology brush (D)

DL Brush (C), RX cytology (B)

Brush cytology of biliary or pancreatic strictures

Plastic biliary stents (S)

Cotton Leung (C), Advanix (B), Olympus Stent

Drainage for biliary decompression in acute cholangitis; drainage for malignant biliary obstruction; drainage and dilation of benign biliary stricture; drainage for pancreatic stricture or stone obstruction

Plastic pancreatic stents (S)

Geenen (C), Zimmon (C)

Drainage of PD to prevent post‐ERCP pancreatitis; dilation of PD stricture, assists with needle‐knife precut of biliary sphincterotomy or minor papillotomy

Stent introducer system

OASIS (C), Naviflex (B), Fusion OASIS (C)

Deployment of biliary or pancreatic stent for drainage

Open mesh SEMS

Wallflex (B), Zilver (C), Evolution (C)

Drainage for malignant biliary obstruction

Fully covered SEMS

Wallflex (B)

Drainage for malignant biliary obstruction; selected cases with benign bile duct stricture

Nasobiliary catheter (S) Nasopancreatic drain

Pigtail, angled tip (C), Straight tip (C), Flexima NB catheter (B)

Temporary drainage of bile duct in acute cholangitis and stone obstruction; less commonly used for PD drainage

Stent retriever (Snare)

Mini micro snare (C)

Snare for removal of indwelling stent

Stent retriever (forceps)

Rat tooth forceps (O)

Forceps to grab and pull the distal end of the stent

Stent retriever

Soehendra stent retriever (C)

Adapted for dilation of tight biliary or pancreatic strictures

Injector

Sclerotherapy needle (C)

Injection therapy; control of post‐sphincterotomy bleeding

Drainage

Miscellaneous

(B), Boston Scientific; (C), Cook Endoscopy; D, double lumen; Inflation with contrast: Con, air: A; LW, long (guide) wire; (O), Olympus; S, single lumen; SW, short (guide) wire; T, triple lumen.

Biliary dilation balloons are usually 4 cm in length, and 4, 6, 8 or 10 mm in diameter placed over an 8 Fr catheter. There are two radiopaque markers placed over the two ends of the balloon for proper positioning under fluoroscopy during dilation. The smaller size balloons are used with pancreatic stricture to avoid injury to the pancreas. Larger CRE™ balloons (up to 20‐mm diameter) are used for biliary sphincteroplasty to assist with removal of large CBD stones. Plastic Stents

These are shaped plastic tubes used either for palliative drainage of malignant obstructive jaundice or for temporary decompression of the biliary system in patients with obstructing stones or strictures with or without cholangitis. Multiple stents have been placed (and

2  Preparing the Facilities and Equipment

exchanged) for continued dilation of benign bile duct stricture after balloon dilation. Smaller stents with a different design are used for drainage of the pancreatic duct (Geenen stent, Cook Endoscopy, Winston Salem, NC). The commonly used biliary stent designs are 7, 8.5, 10, and 11.5 Fr diameter, with either a “straight” (actually slightly curved) shaft with retaining flaps at both ends (e.g. Cotton‐Leung stent, Cook Endoscopy, Winston Salem, NC), or with pigtails (Zimmon’s stent, Cook Endoscopy, Winston Salem, NC). Self-Expandable Metal Stents (SEMS)

SEMS are larger than plastic stents and are being used mostly for palliative biliary drainage. Open mesh SEMS are used mainly for palliation of malignant obstructive jaundice. They are used for bilateral stenting, especially for hilar obstruction, to avoid blocking the opposite side. Fully covered (fc)SEMS are used mostly for drainage of distal CBD obstruction. Because they can be removed endoscopically, fcSEMS are now being used for refractory benign bile duct strictures. Cytology Brushes and Biopsy Forceps

These are used to obtain cytological and tissue samples for the confirmation of underlying malignancy. Cytology brushes are contained within a catheter and placed over a guidewire and positioned inside the bile duct across the stricture or obstruction. The brush is then pushed out above the obstruction and pulled back through the stricture to obtain cells or tissue sample. The brush is retracted before withdrawal for processing. Small biopsy forceps can be inserted freehand after a sphincterotomy into the bile duct to obtain tissue samples under fluoroscopic guidance. Nasobiliary Catheters

Nasobiliary catheters are designed to provide drainage of the bile duct for a few days and can be used for flushing, irrigation, or repeat cholangiography. They are simply long plastic tubes (with multiple side holes at the distal end) and are placed at ERCP over a guidewire. The tip (pigtail or sharp bend) is anchored in an intrahepatic duct, the proximal end is brought out of the mouth, and then rerouted through the nose. Nasopancreatic catheters have similar design but are rarely being used. Guidewires

Guidewires are important adjuncts for many, if not all, therapeutic ERCP procedures. They vary in sizes and are made of differet materials. Today, most guidewires are made of Nitinol wires with a special outside sheath or coating that offers them the hydrophilic property. Most guidewires have a radiopaque (for positioning), flexible tip to facilitate insertion or negotiation of strictures or intrahepatic ducts. The stainless steel wires are stiffer but tend to kink easily. The fundamental differences exist in their length (“short” = 200–260 cm or “long” = 400–460 cm), diameter (0.018–0.035 ins), coating (hydrophilic or not), and tip flexibility. Their merits and specific uses are described in Chapter 7.

Accesory Storage and Organization of the Work Top Accessories for ERCP should be stored in such a way as to allow for easy retrieval as well as stockkeeping. A limited supply of commonly used items should be kept in the procedure

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ERCP: The Fundamentals

Figure 2.5  Organize accessories within easy reach for retrieval. Do not stack up the accessories; “file” like books in a library with large clear labels; and categorize in groups. Special accessories and tools, including McGill forceps, hemostats, and wire cutter.

room (and restocked after use), with clear labels and displayed on shelves like books in a library (Figure 2.5). Accessories are best stored within closed cabinets or covered shelves to reduce environmental contamination. It may be preferable to group similar items together, while keeping special items separate. The accessories in use or likely to be used for a particular case are pulled and placed on work tops, which can either be a separate cart or pullout shelves from the suspending boom. To minimize cross contamination, it is necessary to separate the clean and soiled (used) items. It is important to ensure that the opened accessories are properly maintained during the procedure and kept from contamination so that they can be reused safely if needed. Long accessories such as guidewires, tend to uncoil and they are best kept looped and restrained with a clip or a piece of wet gauze. Others have used clean plastic bags to hold the coiled accessories when they are not in use. Most of the accessories used today are disposable (one‐time use only) but are meant for use on one patient and not one attempt. It is helpful to establish a preprocedure “game plan” by briefing the assistant as to the nature of the procedure and the necessary accessories so that the appropriate and required items can be pulled before start of a procedure.

­Electrosurgical Unit (Diathermy) The diathermy unit provides both cutting and coagulation currents, either separately or in combination (blended mode). Depending on the model, the power setting on the diathermy machine can be preset (e.g. Erbe unit) or adjusted according to individual’s preference (e.g., ValleyLab or Olympus unit).

2  Preparing the Facilities and Equipment

The power setting on different diathermy units varies, depending on the energy output of the machine. For the Olympus diathermy unit (e.g. PSD‐20 or equivalent), the power is set at 3–3.5 with a blended current; the setting on a Valleylab diathermy machine (a 60‐W unit) is a power setting of 30–40 W on cut with a blended I current. The power setting on the Erbe unit is already preset for ERCP sphincterotomy (Endocut mode). It has a unique design that initially coagulates followed by cutting of the papilla, thus, allowing the sphincterotomy to be performed in a controlled manner. The endoscopist can also control the cut by using the foot pedal or alternatively by using the built‐in microcomputer when the unit is activated by the foot pedal.

­Additional Items A resuscitation equipment (crash cart) should be readily available nearby. Usually oxygen is delivered with nasal cannula at a rate of 2‐liter flow per minute. However, for those patients who are mouth breathers (desaturation can occur despite increasing the nasal oxygen flow), it is worth considering the use of the procedural oxygen masks (POMs), which is a modified face mask with an opening to accommodate the endoscope but serves to maintain good oxygenation for the patient. Similarly, bite blocks, nasal trumpets, and other devices should be available to help maintain an open airway during the examination. Contrast should be drawn up in clearly labeled syringes prior to the procedure and be ready for use. It is preferable to have at least two 20‐mL syringes filled with contrast of normal and half‐normal concentration. A 20‐mL syringe is handy for contrast injection because it is easy to handle, contains sufficient volume, and permits injection by the endoscopist. Other items to facilitate ERCP include a small pot of 30% isopropyl alcohol in sterile water (non‐flammable), which is used for cleaning gloves (finger tips) or to wipe down the guidewire during exchanges to remove any bile or contrast, which can become sticky when dried. The dilute alcohol solution also reduces friction at the biopsy valve and facilitates insertion of larger accessories. Gauze pads (4”x4”) are used for cleaning and wiping. Care is taken not to use the dilute alcohol solution for flushing or irrigation in the biliary system. Sterile water with a dilute concentration of simethicone can be flushed down the instrument channel to remove gas bubbles in the duodenum to improve visualization during the procedure. It is of note that endoscope companies caution endoscopists about this practice because the solid residue of simethicone can affect proper reprocessing of the duodenoscope. It should not be used in the water bottle with the air/water channel because this small channel cannot be properly cleaned, and residues can block the channel, leading to costly repair. Additional 20‐mL syringes are used for aspiration of bile for culture or cytology. Sterile water is sometimes used to flush the catheters prior to insertion of hydrophilic wires and for exchanges, although this is not absolutely necessary. Sterile water can be used for irrigation and flushing of the bile ducts to remove biliary sludge and clear residual stone fragments.

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A pair of McGill forceps is useful in assisting with rerouting of nasobiliary catheter. A mucus trap is useful for collecting duodenal aspirate, which represents the bile sample for culturing purposes. It is necessary to disconnect the trap before withdrawing the scope to decompress the stomach content to reduce the chance of contamination.

­Personnel Protection Details of radiation protection equipment and practices are given in Chapter 12. External impervious gowns should be worn on the outside of the lead apron (to minimize contamination) in addition to (double) gloves and shoe covers as appropriate. The endoscopist and assistant should consider wearing protective lead glasses to minimize the risk of early cataract. Staff should wear a face shield or mask to avoid splash injury (Figure 2.6).

­Conclusion Proper physical organization of the room, accessories, and all equipment (including endoscopic, anesthetic, and ultrasound equipment, where possible, and good coordination with the team are essential for ERCP. The choice of accessories will depend on the type of procedures and endoscopist’s preference, but familiarity with all the equipment is crucial to success.

Figure 2.6  Personnel protection according to the Occupational Safety and Health Administration (OSHA) regulations: Gowns, gloves (double), shoe cover, face shield or mask, lead apron and collar, X-ray badge, and lead lining for room and warning signs.

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3 ERCP: The Team Phyllis Malpas Digestive Disease Center, Medical University of South Carolina, Charleston, SC, USA

Key Points ●●

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ERCP is a complex set of procedures that requires the collaboration of many disciplines and staff members. Initial and continuing education, demonstrated competency, and mutual respect for all the talents are essential for optimal outcomes. ERCP is a team event, involving a broad range of talents, training, understanding, and action inside and outside the procedure room. Good outcomes, including success and patient safety, depend on wise, thoughtful, and well-prepared clinicians, a knowledgeable and competent staff, mutual respect, and multiple levels of support. The patient’s needs are top priority, and privacy must be protected. The ERCP team is only one section of the whole unit.

Back to the mid‐ to late 1980s, ERCP was coming into its own as a therapeutic specialty of gastrointestinal (GI) medicine and nursing. As a team member in ERCP, I was working alongside devotees such as Jeffrey Ponsky and Roy Ferguson and in earshot of great names, like Cotton, Cunningham, Leung, Geenen, Soehendra, and Huibregste. These names emerged in our conversation and on our devices. It was natural that ERCP became a critical focus of our work. Because we were all in previously uncharted waters, we often did not recognize the how’s, who’s, and why’s of what we needed to create or develop. This chapter, therefore. is to be taken for what it is: an honest review with some words of wisdom gained from long experience as an endoscopy and ERCP team member, and as a nurse manager. It is critical for those seeking to build great ERCP teams to take the time and make the effort needed to grasp the current state, as well as the future vision of the organization within which the ERCP team functions. Failure to bridge any cultural divide can hamper ERCP teams. These gaps may seem slight and appear to be only surface deep. In the long run, however, they can widen into chasms, affecting procedure volume and timing, staffing ­levels, education and expectation of staff training, financing of capital equipment and ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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­ rocurement constraints, physician scheduling and anesthesia, radiology, and infection‐ p prevention practices. Any or all of which can, and will, most importantly, affect patient care and safety. ERCP is among the most complex procedure performed on a regular basis in many endoscopy units and is the quintessential team event. It might be compared to a musical concert. Although some members of the orchestra are more prominent, it is the combination of talents that produce the best music. Equally, it can be ruined if only one member performs badly. Recognizing and valuing the contributions of all members of the team is essential for continuing success. Leaders of ERCP and endoscopy in medicine, nursing, and administration must define and, at times, redefine their combined vision and goals and the culture in the existing and specific organizational structure. Collaboration to translate vision into reality over time provides the solid foundation needed to develop these goals and to orchestrate them well. Building this core is as necessary as the development of the individuals in the procedure room, the appropriateness of the devices handled, and arguably, the skill of the physicians and staff. It is the stage on which the entire orchestra is set and from which the most harmonious music of the best teams is produced. The ERCP front line consists of those in the room with the patient (i.e. the endoscopist[s], primary “table” assistant, a nurse or technician, radiology tech, monitoring nurse, and anesthesia provider). In close clinical support nearby in the unit are those involved in preparing and recovering the patient and caring for family members. Behind the scenes are those who make sure that all the necessary equipment and accessories are available and safe to use. Some of the details may vary according to the site and size of the ERCP practice, but the fundamentals are consistent. The nurse manager and medical director of the unit have the responsibility to ensure that all the elements are in place. All involved must have the necessary initial and ongoing training, to be determined in accordance with unit, organization, association, and regulatory guidelines, while at the same time, providing the proper level of support to the remainder of the unit. There should be no room for prima donnas, and there is no “I” in TEAM because team stands for technician, endoscopist, associates, and management.

E ­ ndoscopy Staff Registered Nurse Each procedure team should include at least one person licensed as a registered nurse (RN) as a first or second assistant. Through education and experience, the RN contributes continuous assessment of the patient and honed critical thinking skills, providing the foundation for patient safety in any situation. For example, in gastroenterology nursing in the United States and Canada, the Society of Gastroenterology Nurses and Associates (SGNA) and the Canadian Society of Gastroenterology Nurses and Associates (CSGNA) is regarded as the gold standard for GI nursing. A sister organization, the GI Nursing Board (i.e. American Board of Certification for Gastroenterology Nurses [ABCGN]) certifies the RN in gastroenterology (i.e. certified gastroenterology registered nurse [CGRN]) through examination. The level of ­education and training, as well as the nomenclature, will vary between countries.

3  ERCP: The Team

GI Technicians, Technologists, Assistants, and Associates Non‐nursing assistants play important roles in the ERCP team. Their training and education varies widely. In United States, the SGNA recognizes the role of “GI technical specialist” with a specific knowledge base through the completion of an education series. Delineation of the role of “assistive personnel” is available as a guideline from SGNA and is updated regularly. Additionally, organizations may introduce technician training through surgical, interventional radiology, or other programs. Determination of the scope of practice for assistants must be vetted by the particular organization, as well as the rules and regulations of the all governing bodies.

­The Team in the ERCP Room First Assistant From the endoscopist’s perspective, the most important immediate staff member is the person (often called the “table nurse” or “table tech”) who sets up the equipment and accessories and manages them throughout the procedure. Educated smooth coordination between this assistant and the endoscopist is essential for success. This is often the main role of the assistant in the unit. Larger volume units may need a cadre of two to four or more such experts, especially if there is any significant chance of needing to perform procedures out of normal working hours. In the United States, depending on the setting, this person may be a RN, a GI technician assistant, or specialist. The skill and contribution of this individual is central to the procedure. As ERCP and therapeutic endoscopy develops and transforms over time, the specific functions of this role must be carefully evaluated through the lens of the organization and regulatory bodies. As mentioned in the opening of this chapter, those of us from the “heyday” of ERCP developed a set of good working ideas, which we carefully hold dear. Today, however, and ever more rapidly, roles in endoscopy are evolving along with the expanding spectrum of therapeutic interventions. The determination of this crucial role is a specific example of the need for collaboration at the program and departmental levels. Taking the time to develop a unified, respectful culture is necessary. With that culture in place, the determination for this critical role will take on its proper perspective. An issue rarely addressed is the need for the endoscopist and first assistant to use agreed terms for their interactions during procedures. Do we “tighten” or “bow’ the sphincterotome? What does “needle out” mean? “Balloon up/down” or “inflate/deflate”? It is important to have a common language among all endoscopists and assistants for proper communication to avoid any misunderstanding and incoordination that may translate into a different outcome. Such frustration can occur when new “experienced” staff from other institutions join the team.

Second Assistant A second assistant backs up the table nurse or technician and is also critical. This assistant circulates in the room, keeping careful observation of the patient, including positioning and comfort, arranging accessories, perhaps preparing specimens, providing additional

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endoscopes, and, as appropriate, documenting the procedures. These individuals often become competent at multitasking and indeed can provide useful continuity while other team members change. They may also become responsible for maintaining the inventory of accessories.

Anesthesia, Sedation, and Monitoring Many standard ERCP procedures can be, and are, done under moderate (conscious) sedation given by another RN under the endoscopist’s supervision. However, there is a trend toward the increasing use of anesthesia (modified or full), especially for complex procedures in patients who are sick. Although ERCP is carried out by a special team of trained staff, it is a more involved and prolonged procedure that sometimes requires more sedation medications than a routine endoscopy. It is critical to reserve the time needed before the procedure to comprehensively communicate with the preparation team regarding the patient’s sedation and anesthesia ready status at the time of ERCP. The team should be alert to the possibility of desaturation and hypoxia during the examination and ways and means to resuscitate or support the patient for the endoscopist who may require the extra 1–2 minutes to complete a lifesaving procedure (e.g. placement of a biliary stent to ensure drainage). The key members should have advanced cardiac life support (ACLS) certification with regular drills catered to managing such a potential complication.

Radiology Fluoroscopy and filming are usually done by a radiology technologist (radiographer) in collaboration with the endoscopist. Busy units are able to appoint their own radiographer, who can become knowledgeable and helpful. Trying to do complex procedures with a technologist who is rotating through the unit and unfamiliar with ERCP can be frustrating. Radiation safety is an important consideration; more details are given in Chapter 12.

­The Team outside the Procedure Room Lead ERCP Endoscopist High‐volume units with several ERCP endoscopists should appoint a lead endoscopist who can work with the nurse manager to ensure that procedures and training go smoothly. This individual also acts as an effective liaison with equivalent leaders in other involved disciplines, especially Anesthesia and Radiology.

­Clinical Support in the Unit Preparation and recovery of patients who have undergone an ERCP is little different from those undergoing other procedures and are handled by the same staff. Careful monitoring after ERCP is important because of the risk of serious adverse events, especially pancreatitis and perforation.

3  ERCP: The Team

Endoscopes and Their Care Those responsible for reprocessing endoscopes are key members of the team and always must be regarded as such. Make no mistake, every individual who comes in contact with the endoscope is responsible for its care at all times. Particularly as revealed in 2015, endoscope care and design as well as reprocessing lapses are responsible for serious outbreaks of infection after ERCP. This important issue is addressed in Chapter 4. We often speak of the endoscopes as “instruments.” Let’s take a moment to return to our analogy of the orchestra. In any orchestra, the instruments are treasured and of critical significance. The proper handling and care of these endoscopes, our instruments, cannot be overestimated. At no time would a violinist place his or her violin in danger of being mishandled, broken, slammed, smashed, or pushed beyond its capability. No orchestral instrument is left to inappropriately collect debris. Every step is taken to protect and properly care for any instrument in an orchestra. Endoscopes are our instruments and our key to excellence in the care of the patients we serve. Everyone should be trained on appropriate endoscope use and care. Familiarity with specific instructions for use (IFU) from manufacturers is vital.

Technical Support in the Unit Equally important are those who order, procure, stock, manage, and maintain all of the other equipment, including the increasing amount and complexity of information technology.

Outside the Unit The staff who see the patients in the clinic or office before ERCP, and those who schedule the procedures prior to ERCP, as well as further appointments and examinations, have important roles in ensuring that all relevant clinical data (e.g. imaging discs and reports) are available and for helping to educate patients and family members. Finally, we should acknowledge the contribution of our industry partners, who provide the equipment we need and, in some instances, collaborate on developing new devices.

E ­ ducation Nurses and technologists chosen to work in ERCP are usually selected from the whole unit staff and, thus, will have a broad understanding and often extensive experience of the technical and clinical aspects of the practice of endoscopy in general. They may confirm their interest in becoming part of the ERCP team by watching some procedures and absorbing the often complex dynamics in the room. Specific training is required concerning some key facts of ERCP practice, including: ●● ●● ●●

pancreatic and biliary anatomy and diseases, the range of ERCP therapeutic procedures, the specialized accessories,

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radiation safety, and the specific risks and how to minimize them.

Most of this can be learned through the plethora of available materials in books, journals, and web sites (especially those of the major national and international professional societies) as listed in the Further Reading. In medical schools, staff may join didactic sessions in concert with other trainees, such as fellows. Clearly, staff need time for these educational activities. This chapter includes the foundation of an ERCP Education and Training Plan, which includes steps for all staff who may work in the ERCP arena, followed by steps of bench training for those advancing to key procedure roles, and training suggestions for mentored hands on ERCP intraprocedural training. This structure can be adapted to meet the particular needs in each setting (Figures 3.1 and 3.2). Engaged physicians, nurses, and technologists, who are regular members of the ERCP team, are expected to support trainees and share their expertise by providing thoughtful information and instruction. All questions from learners and observers should be respectfully entertained within inevitable time constraints. How to manage specialized accessories should be taught with an experienced mentor, initially “on the bench,” and then with sequential responsibility during actual procedures. Training advances safely in a step‐by‐step fashion in an atmosphere of being “walked and talked” through techniques alongside a mentor as skill develops. The endoscopist(s) also needs to be sympathetic and supportive during this phase. Experienced nurses and technicians should have the opportunity to attend regional and national meetings.

I­ ndustry Partners Endoscope and accessory manufacturers and suppliers are (not surprisingly) anxious to participate in the education of the staff and can be helpful by supplying teaching materials

Figure 3.1  Hands-on educational practice between trainee and mentor. Discussion on handling guidewire and double-pigtail stent.

3  ERCP: The Team

Figure 3.2  ERCP: The Team. Radiology tech, table nurse, ERCPist, certified registered nurse anesthetist (CRNA), second assistant, and nurse coordinator.

and organizing demonstrations. However, there are some potential pitfalls if the relationship is not managed effectively. There may be undue influence on purchasing decisions, regardless of cost or actual clinical need, and there can be problems with patient confidentiality. These problems can be overcome by having strict rules concerning these interactions and the expectation that the entire team will abide by them. In particular, product representatives should be admitted to the unit only by appointment with a specific agreed agenda.

­Motivation and Team Building Two general principles apply here as anywhere: respect for each team member’s skills and contributions and sensitivity to their agendas. This applies particularly to members with different reporting streams (e.g. Anesthesia and Radiology). Scheduling clashes are a potent cause of friction and unhappiness. Endoscopists should realize that compliments on a job well done are always appreciated, but criticism is best given privately after the event. Those who (sadly) still posture and denigrate during procedures poison the atmosphere and lay the groundwork for further errors. A list of procedures is likely to go better if the key people understand what is planned ahead of time. Thus, many successful teams have a huddle each morning to describe the cases and likely needs. Additionally, there should always be a time out before each ­procedure. Although this was introduced for safety reasons (e.g. wrong patient, radiation

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protection, etc.), it can be expanded to explain the specifics of the case so that each member is on message. A preprocedural game plan or discussion between the endoscopist and assistant(s)/trainees regarding the nature and any specific needs will also facilitate individual procedures and minimize any unnecessary delays. Staff will appreciate some feedback about previous cases, whether good or bad. Whenever possible, key staff members should be included in other aspects of the ERCP service. Thus, they may be invited to attend case conferences and meetings about ERCP‐ related research.

P ­ itfalls Additionally, to the risks already mentioned, to succeed day by day it is important to maintain focus on the primary reason for all of these activities, the individual patient. In the rush and excitement of high‐tech procedures, it is easy to lose track of patient specific needs and privacy. Constant vigilance must be maintained to recognize and prevent the development of a casual atmosphere of everyone doing “this” before. It is crucial to address such a tendency, in particular for preceptor or mentor nurses and technicians and key physician ERCP partners. ERCP teams must continue to recognize that they constitute only one section of the whole‐unit orchestra. Their individual expertise in the orchestra must not be allowed to affect the melodies the orchestra is geared to create. The closed door needed for radiology should not promote a closed‐door mentality for the ERCP team.

R ­ esources Endoscopy units should have a library, which includes details of local policies and procedures and educational resources, both printed and online. Units lucky enough to have a formal nurse educator will be able to manage these and add key journal articles, support the development of further training opportunities, and monitor progress over time.

C ­ onclusion Although teams involve any number of people, they appear only in relation to the commitment of each person. The greatest teams are both highly individual and solidly united. ERCP teams and teamwork involve ownership by all those involved, inside and outside the room—and the proof is in the pudding! The team advances safely, knowledgeably, efficiently, and compassionately, combining high technology and the human touch for all with whom it comes in contact. It is my hope that this chapter contributes to current and future high‐functioning teams, who are valued and recognized for their contribution every day in support of the patients served.

3  ERCP: The Team

Further Reading Books Cotton PB, ed. Advanced Digestive Endoscopy: Practice and Safety. Chichester: Wiley‐Blackwell;2008. Cotton PB, Leung JWC. ERCP; the Fundamentals, 2nd ed. Chichester: Wiley;2015. Dhir RK, Green JW, eds. Protection of Concrete. Chichester: Wiley;1990. Haycock A, Cohen J, Saunders B, et al. Practical Gastrointestinal Endoscopy; the Fundamentals, 7th ed. Chichester: Wiley Blackwell;2014. Khashab M, Robinson T, Kaloo A, eds. The Johns Hopkins Manual for GI Endoscopic Nurses, 3rd ed. Thorofare, NJ: Slack Incorporated; 2013. Society of Gastroenterology Nurses and Associates (SGNA). Manual of Gastrointestinal Procedures, 7th ed. Chicago: SGNA; 2018. Society of Gastroenterology Nurses and Associates (SGNA). Gastroenterology Nursing: A Core Curriculum, 5th ed. Chicago: SGNA;2013.

Journals (many of which include society guidelines and technology) Gastroenterology Nursing Journal Gastrointestinal Endoscopy Endoscopy

Professional Societies American College of Gastroenterology (ACG). www.gi.org Association for the Advancement of Medical Instrumentation (AAMI). www.aami.org American Society for Gastrointestinal Endoscopy (ASGE). www.asge.org Canadian Society of Gastroenterology Nurses and Associates (CSGNA). www.csgna.com European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). www. esgena.org Society for Gastrointestinal Nurses and Associates (SGNA). www.sgna.org

Education and Training Plan: Didactics, for any staff assigned to ERCP room ●● ●● ●●

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Overview: use related to common diagnoses and treatments Patient details including anesthesia and positioning Detailed anatomy and some physiology –– Drawings of pancreato‐biliary system and surrounding anatomy –– Links to informative websites or apps –– Photographic and fluoroscopic images, stills, and video Overview of general equipment and accessory types, including introduction to and importance of instructions for use

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Procedure room observation with preceptor, not hands on –– Endoscope, diagnosis, therapy, radiation safety ○○ including endoscopic and fluoroscopic images –– Observational focus on care of patient and room turnover –– Focus on basic device setup and table management –– Specialized care for duodenoscope –– Coordination between endoscopist and table assistant

On the Bench, Table Top, Dry Run—for staff who will take on a technical role ●● ●●

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Teach on the basics of endoscopy; build on solid foundation Build equipment platforms in a step‐by‐step fashion –– Diagnostic basics: cannulas, guidewires, and sphincterotomes ○○ Add variation(s) and specifics ○○ Include advancing platforms (e.g. dilation, stone extraction) Talk through procedure use based on prior endoscopy experience –– ERCP didactic and in room observation Dry run: “hands on” encourages question‐and‐answer format Present industry information, manuals, and instructions for use –– Obtain samples or training devices Component fit, sizing, progression, and transfer of devices –– Use color guides and package indicators Demonstrate position of side‐view scope and landmarks –– Use models when appropriate and available

Hands‐on in Procedure—for table staff following solid mastery of Bench Training. Must be accompanied by key mentor or preceptor ●● ●● ●● ●● ●●

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Set goals for precepted procedure numbers Enlist the assistance of the ERCP endoscopist in advance Seek therapeutic procedures related to patient diagnosis Hold a huddle prior to case schedule to discuss upcoming procedures Mentor and trainee work closely together with dialogue –– Handle specialty and infrequently used instruments Use industry partners for training when necessary Design tools to determine competency following training

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4 Minimizing Duodenoscope Infections Catherine Bauer University of Virginia Medical Center, Charlottesville, VA, USA Society of Gastroenterology Nurses and Associate President 2018–2019

Key Points ●●

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Duodenoscopes are complex instruments and are more difficult to clean than other scopes used in the endoscopy department. Pre‐cleaning at the bedside immediately after the procedure is of critical importance. A strict protocol for reprocessing and methods for validating its effectiveness will minimize the risk of cross contamination and ensure patient safety. Understanding the issues and the steps in the reprocessing process will assist physicians when speaking with patients about infection issues. All staff in the unit must participate actively to minimize infection risks.

I­ ntroduction The reports of several outbreaks of serious infections and deaths in recent years resulting from contaminated duodenoscopes has forced our profession, regulators, and equipment manufacturers to review and improve the quality of reprocessing and to explore other solutions. Our national societies (American Society for Gastrointestinal Endoscopy [ASGE], American College of Gastroenterology [ACG], American Gastroenterological Association [AGA], Society of Gastroenterology Nurses and Associates [SGNA], and ­others) and relevant federal agencies (Centers for Disease Control and Prevention [CDC], Food and Drug Administration [FDA], etc.) have all weighed in [1]. This chapter will cover how to minimize infections from ERCP scopes. Because infection prevention is the responsibility of everyone in the department, it is important that all are aware of the steps taken to prevent this complication.

ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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ERCP: The Fundamentals

P ­ atient Selection Infection prevention starts with patient selection and understanding that this is a high‐risk procedure and should only be performed on patients that need it. With better radiologic imaging, ERCP has become a therapeutic tool to be used when prior imaging shows a ­problem that is best managed by ERCP.

­Scope Reprocessing Steps There are seven defined steps in the use and handling of the scope, from taking it out of storage to returning it back to the storage cabinet after reprocessing. It is important to ­follow strictly the manufacturer’s instructions for use (IFU) in using and reprocessing the endoscope. Pressuring staff to turn over the scopes quickly and bypassing some of these important steps can result in improper scope reprocessing and risk to the patients. 1) Pre‐Cleaning: This process starts immediately after the scope is removed from the patient and helps to prevent bioburden from forming on the surface and internal channels of the scope. This is done by flushing the channels with an enzymatic cleaning solution and wiping down the outside with a lint‐free cloth. With ERCP scopes, there is another step to this process because of the elevator. When suctioning the solution through the channels, move the elevator up and down while agitating the tip in the solution. You will see any stones, sludge, and other bodily fluid release from the back of the elevator, which is the main area in which problems can develop more easily. 2) Leak Testing: Once the scope has been transferred to the reprocessing area, the first step is to perform a leak test, which will identify any damage to the scope that would cause fluid invasion if submerged in water. It is important that this leak test is done correctly to prevent damage to the scope, and all the channel buttons are removed. Attaching the leak tester to the scope is done while outside of the water, inspecting the distal bending area of the scope to assure the leak tester is working. A slight inflation of the bending rubber should be seen. When the scope is placed in the water for inspection, the whole scope should be submerged, including the handle, and any air bubbles released from the scope should be noted. The up/down and left/right knobs on the head of the scope should be rotated while watching for bubbles. All of the nonremovable controls on the scope handle should be depressed to ensure that there are no micro‐ leaks. If there are no leaks, the scope should be completely disconnected from the leak tester and removed from the sink. If a leak is found, then the scope will need to be ­prepared for repair. 3) Manual Cleaning: Manual cleaning to remove residual debris from the scope is the most critical step in the disinfection process. It is essential to ensure that every step in the process is followed completely. This includes brushing the channels of the scope, including the control buttons and biopsy valve ports with a validated brush to remove debris. Brush the tip of the scope in front and behind the elevator. Using a magnifying light is helpful in this step. Using the brush that is validated and recommended by the scope manufacturer’s IFU is the best way of knowing the entire surface of the scope is

4  Minimizing Duodenoscope Infections

covered. Flushing the channels after the brushing is complete with enzymatic cleaning solution assists in removing debris that is loosened during the brushing process. The last step in the manual‐cleaning process is rinsing the scope of any enzymatic cleaning solution to prevent dilution of the high‐level disinfectant. 4) Visual Inspection: After the manual cleaning is complete, it is important to do a visual inspection of the scope to see if there is any damage, debris, or need for further manual cleaning before sending it on for high‐level disinfection. Manufacturers recommend no longer than 60 minutes from manual cleaning to high‐level disinfecting or sterilization. 5) Disinfection: Placing the scope in the Automatic Endoscope Reprocessor (AER) or sending it for sterilization is the next step in the cleaning process. Make sure that the AER has been validated for the type of scope being reprocessed. When placing the ERCP scope in the reprocessor, the elevator should be in the neutral position to provide the most exposure possible to the disinfecting solution. The scope should sit in the basin of the reprocessor without any kinks or extra loops and should be fully submerged. The solution is tested after each scope is reprocessed to validate that the chemical concentration is sufficient. Some systems have one‐time use disinfectants. An alcohol flush is used to facilitate the drying process; this can be programmed into the AER or completed manually after removal and then flushed with air. Drying is a critical element in ­reprocessing. Moisture allows microorganisms to survive and multiply; therefore, all channels and surface of the endoscope must be thoroughly dried before storage [2]. 6) Storage: The scopes should be completely dried before being placed in a clean, ventilated cabinet for storage. The storage cabinet should allow the scope to hang freely ­without touching the bottom or sides. There are options for horizontal storage; this must be a cabinet validated for this type of scope if they are going to be stored in that manner. There is no standard length of time a scope can remain in storage before ­needing reprocessing; more research is needed. A systematic review completed in 2015 concluded that endoscopes can be stored for 7 days if they have been effectively reprocessed and are stored in a way that keeps them completely dry and free from environmental and human contamination. Another study found no problem after 21 days [3]. 7) Documentation: Units should document the completion of scope reprocessing, along with daily and weekly testing of the system. Examples of documentation include the effectiveness of the high‐level disinfectant after each use. Scope use, including repair (life history), is recorded by using a unique identifier for each scope, such as the manufacturer’s serial number. This should be recorded in the patient’s chart to be able to investigate any possible infection event. 8) Ethylene Oxide Sterilization: Some experts consider scopes as critical instruments and, therefore, should undergo sterilization as part of reprocessing. All scopes must go through the manual‐cleaning process before transported to the sterile‐processing department for sterilization. Sterilization usually takes approximately 16 hours. This poses a number of challenges. It can limit the number of procedures and increase the need to purchase additional scopes to avoid interruption in patient care. Additionally not all facilities have the equipment available to perform sterilization or the infrastructure to support the process. There is also concern about possible damage to endoscopes by such sterilization processes.

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S ­ taffing The skill and experience of the staff involved with reprocessing the endoscopes should be validated yearly and audited quarterly to maintain confidence and quality control in the reprocessing system. Certification in flexible endoscope reprocessing is also helpful in creating a high level of confidence among the staff, and this may soon become a requirement. Several options are available, including the International Association of Healthcare Central Service Material Management (IAHCSMM) certification test, which requires working experience of 3 months before taking the exam, in addition to continuing education credits specific to reprocessing endoscopes for recertification [4]. The Certification Board of Sterile Processing and Distribution (CBSPD) has been around for a number of years and also provides a certification exam for flexible endoscope reprocessing [5] This requires 12 months of working experience before being eligible to take the exam. It also requires continuing education credits specific to endoscope reprocessing for recertification. The staff who clean and reprocess scopes perform a crucial duty. It is important to emphasize the importance of what they do and keep them motivated and informed of any concerns that may arise. Giving real‐time feedback during audits is one way to do that. Educating the staff on what the scope does, how it is being used, and why is a great way for physicians to be involved with the staff caring for the scopes used [6].

­What Progress Is Being Made? Endoscopy Units All units should be validating their reprocessing procedures. Some are putting scopes through the process twice, either at the time, or for a second time, immediately before the ERCP. Many are taking cultures every few weeks for quality assurance. Some are culturing all scopes after reprocessing and putting them “in quarantine” until negative results are returned. This method obviously involves increasing the scope inventory. A few centers use ethylene oxide sterilization [7]. Hospitals should keep track of all relevant infections and monitor to see if there are any links to recent ERCP procedures. The FDA is coordinating a microbiological surveillance program around the United States. Their report early in 2019 from units that knew they were being evaluated was not reassuring. They report: “For high concern organisms, defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa, updated culturing results appear to show that up to 5.4% of properly collected samples tested positive, which is an increase from the 3% contamination rate that was previously reported” [8]. Endoscope manufacturers are actively addressing this problem. In addition to all of the instructions that they give about reprocessing, they have made some changes to the instruments. New versions allow better access to the elevator area (a major source of contamination) with a removable cap. A disposable duodenoscope has been developed. If adapted, the costs involved may confine ERCP practice to fewer centers. As a reminder, scopes used for endoscopic ultrasound are also difficult to reprocess, and similar concerns apply.

4  Minimizing Duodenoscope Infections

C ­ onclusion Minimizing infections related to the use of duodenoscopes is everyone’s responsibility. Understanding the importance of every step in reprocessing and maintenance of endoscopes is just as important to the endoscopist as it is for the staff performing the reprocessing. Assuring patients that every effort is made to reduce the risk of contamination and infection is part of the physicians’ responsibility during the process of informed consent. Providing continuing education and presentations to the staff in the department on how specifically to prevent infections is a role that physicians should welcome and support. Partnering with the infectious disease department in the facility to create a culture of trust and support will assist the staff and department in providing exceptional care for scopes and for patients.

R ­ eferences 1 Reprocessing Guideline Task Force, Petersen BT, Cohen J, et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointest Endosc 2017;85:282–294. doi:10.1016/j.gie.2016.10.002. 2 Society of Gastroenterology Nurses and Associates. Infection Prevention. Available at: https://www.sgna.org/Practice/Infection‐Prevention/Infection‐Prevention‐Toolkit/ Professional‐Society‐Guidelines. Accessed May 13, 2019. 3 Schmelzer M, Daniels G, Hough H. Safe storage time for Reprocessed Flexible Endoscopes: A Systematic Review. Dallas: JBI Database of Systematic Reviews & Implementation Reports, 2015. 4 International Association of Healthcare Central Service Material Management. Certification. Available at: https://www.iahcsmm.org/certification.html. Accessed May 13, 2019. 5 Sterile Processing. Flexible endoscope reprocessing. Available at: http://www. sterileprocessing.org/gi.htm. Accessed May 13, 2019. 6 Healthcare Infection Control Practices Advisory Committee (HICPAC), Center of Disease Control and Prevention. Essential elements of a reprocessing program for flexible endoscopes recommendations of the HICPAC. Available at: https://www.cdc.gov/hicpac/ recommendations/flexible‐endoscope‐reprocessing.html. Accessed May 13, 2019. 7 Ma GK, Pegues DA, Kochman ML, et al. Implementation of a systematic culturing program to monitor the efficacy of endoscope reprocessing: outcomes and costs. Gastrointest Endosc2018;87:104–109.e3. doi:10.1016/j.gie.2017.05.001. 8 US Food and Drug Administration (FDA). The FDA continues to remind facilities of the importance of following duodenoscope reprocessing instructions: FDA safety communication. Available at: https://www.fda.gov/medical‐devices/safety‐communications/ fda‐continues‐remind‐facilities‐importance‐following‐duodenoscope‐reprocessing‐ instructions‐fda.

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5 Patient Education and Consent Peter B. Cotton Digestive Disease Center, Medical University of South Carolina, Charleston, SC, USA

Key Points ●● ●● ●● ●●

●●

●●

ERCP is the most dangerous common endoscopy procedure. Patient education is primarily the responsibility of the endoscopist offering ERCP. Staff can assist, and brochures and websites are useful adjuncts. The interaction should be in a relaxed clinic-type environment, with time for questions and reflection, preferably not on the day of the procedure, and with a family member present. Information must include expected benefits, potential risks, known limitations, and any alternatives. The consent process must be clearly documented.

ERCP can be beneficial but can also result in serious injury. No one can dispute the need to make sure that patients (and those on which they rely for support) understand precisely what is being proposed and why, so that they make an informed decision whether or not to proceed. Consent is an education process and not a piece of paper to be signed at the last minute. It can be achieved only in the context of an effective provider‐patient relationship. Except in urgent cases, this process should start well before the planned procedure and not on the same day. In fact, the widespread use of anticoagulant and antiplatelet agents often makes it necessary to make informed decisions a week or two ahead of time. These are not trivial issues. Balancing the risk of bleeding against the risk of stroke needs thoughtful consideration and, often, specialist consultation. The education process should involve a face‐to‐face, sit‐down, fully clothed consultation with the endoscopist concerned and include a family member if possible. The endoscopist should explain the reason why he or she is proposing the procedure based on full disclosure of all of the key elements, that is, the potential benefits (what it should achieve), the known limitations (why it may not work), the major risks, and any relevant alternatives. Note that

ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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ERCP: The Fundamentals

one of the alternatives in patients with complex histories is to offer referral to a tertiary center. The consent process must include adequate time for questions. Additional useful information can be provided beforehand by nurses and other staff and with explanatory brochures. Many brochures are available from professional and other bodies, but I recommend developing one that is tailored to the local environment and your own practice. An important issue is how deep to go into the details (e.g. do you mention death?) in the presentation and any written materials. That is a matter of judgment for endoscopists based on their assessment of the patient at the time. It is smart to underplay the potential benefits, and to emphasize the risks, rather than the reverse. Those who say: “Just sign here. We do this every day, don’t worry about it” are ­asking for trouble. Figure  5.1 show the materials that I developed and used. Feel free to copy and adapt them. The consent form can then include the statement, “I have read the explanatory ­material and have had the opportunity to ask questions.” Be aware of content on the Internet, and beware, that not all of it is accurate or helpful. It is wise to ask patients what they have read about the procedure or, indeed, heard about it from friends. Some may have heard about the risk of nosocomial infection.

­Documenting the Process Is Important Modern electronic report writers make it possible to generate several sentences about obtaining consent at a single keystroke. Plaintiffs and their lawyers are always skeptical about the accuracy of that information when there is (always) a dispute about what was said. Thus, it is ideal to handwrite or personally dictate what you do and, preferably, have it witnessed by a staff member Communication is not a one‐way exercise. We usually assume that patients hear and understand what we say, but research shows that is rarely the case, for many reasons. Perhaps we should conclude with a short test? What did you hear me say about the risks or the alternatives? Or we could even give a short written quiz. Better still, we would like to see greater use of interactive web‐based education and consent systems that take patients through a journey and that provide a permanent record. Patients can delve in as deeply as they wish. A proper consent process is good medical practice, but it is also essential when, inevitably, there is a bad outcome. It is then possible to be able to say, for instance, “the X‐ray confirms a perforation; you remember that we talked about that rare possibility yesterday, don’t you?”

­Conclusion The task of preparing patients emotionally and intellectually for therapeutic interventions is a serious and enjoyable obligation. It is part of the privilege of being a doctor, and not just a technician. Do it well.

5  Patient Education and Consent

ESOPHAGUS

LIVER STOMACH

BILE DUCT

CYSTIC DUCT PANCREAS

CT

DU

GALL BLADDER MINOR PAPILLA MAIN PAPILLA

SPHINCTER OF ODDI DUODENUM

Figure 5.1  The ERCP explanation document that I used in practice.

­Outstanding Issues ●● ●●

How best to make sure that patients and families understand what we say? How to document the success of that communication?

­Further Reading Cotton PB. Medico‐legal issues. in Baron, Kozarek, and Carr‐Locke, eds. ERCP, 3rd ed., 99–107. Philadelphia: Elsevier, 2018.

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6 Risk Assessment and Reduction Erin Forster and Joseph Romagnuolo Department of Medicine, Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA

Key Points ●●

●●

●●

The most common adverse events after ERCP include pancreatitis, bleeding, infection, and perforation, as well as cardiopulmonary events. Rarely, ERCP can cause chronic disability or be fatal. The actual risks in an individual depend on the context of the procedure, the characteristics of the patient, the skills of the procedure team, and the appropriate use of prophylactic interventions. Understanding and managing these interacting issues are key to making wise clinical decisions and improving patient education and informed consent.

One of the most important concerns surrounding ERCP is its relatively high‐risk profile in comparison to other endoscopic procedures. Post‐ERCP pancreatitis (PEP) is the major concern, with rates ranging from about 5% overall to 15% or more for high‐risk procedures (even after risk‐reducing maneuvers). Other events, such as bleeding, perforation, infection, and cardiorespiratory problems also occur in about 1% of cases  [1, 2]. The likely risk varies greatly between cases. Thus, a biliary stent change in a healthy middle‐aged man can be orders of magnitude safer than manometry and dual sphincterotomy with pancreatic stenting in a young woman with prior PEP. This adverse event profile makes it important to ensure training is both sufficient and appropriate for the endoscopist and the team or unit to ensure indications are sound, noninvasive alternatives are considered, and patients are appropriately informed and consent to the risks, benefits, limitations, and alternatives. A critical step toward reducing risks is to understand their predictors [3, 4]. Some factors may be modifiable, and their identification allows time to address them. For nonmodifiable considerations, identifying the risks preoperatively may lead to a change in plan (perhaps to an alternative to ERCP) or hypervigilance during and after the procedure. This chapter will focus on the identification of patient and procedural and periprocedural factors that increase risk and will not focus on definition of risks, documentation of ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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risk or events, or the ideal ERCP technique that might lower risk because those are discussed in more detail in other chapters. Some procedural factors are mentioned briefly, however, to give perspective on their importance with respect to nonprocedural factors. Table 6.1 summarizes predictors of adverse events after ERCP.

­Assessing and Reducing the Risks As mentioned, there are five main risks attributed to an ERCP: pancreatitis, bleeding, infection, perforation, and cardiopulmonary events. The thresholds for calling these events an “incident” compared with a true “adverse event” are detailed elsewhere [4]. In addition, two other nonclassical risks have recently been given more attention: the risk of technical failure and exposure to radiation. Note that ERCP in pregnancy has its own set of risks.

Pancreatitis and Postprocedural Pain There are many studies looking at predictors of PEP, but there are still some controversies. Normal‐caliber bile duct [8], bilirubin level [13], [prior PEP [13], non‐university center [8], and trainee involvement [14] were found to be predictors in some studies but not in others. Inconsistencies may be the result of not controlling for confounding factors such as ­suspected sphincter of Oddi dysfunction (SOD) and pancreatic therapy in some studies; suspected SOD and pancreatic therapy patients likely have independently higher risk and tend to have a normal bilirubin and normal‐caliber bile ducts. Overall, however, the ­contributing risks for PEP are additive and synergistic. Several other factors are agreed. The list of independent predictors for PEP includes female sex (odds ratio [OR] 1.8–3.5) [13, 16, 17], suspected SOD (OR 1.9–9.7) [9, 13–15], younger age [8, 14, 16], pancreatic injection (OR 1.04–1.5) [8, 13, 14, 20–22] (especially filling to the tail) [21], and pancreatic sphincterotomy (OR 1.5–3.8) [8, 9, 14, 20]. In addition, simply having difficulty with cannulation (OR 1.8–9.4) increases the risk [15, 16, 17, 43], and implies that one’s skill set in cannulation, and the patient factors that might make cannulation difficult, are important cofactors. Long‐standing or advanced chronic pancreatitis with atrophy or loss of gland tissue [8] probably reduces risk given the lower enzyme reserve; on the other hand, minimal‐change pancreatitis probably does not, so these patients should not be reassured that their risk is lower. Pancreatic stenting and rectal ­nonsteroidal anti‐inflammatory drugs (NSAIDs) in high‐risk cases have been shown in randomized trials to be beneficial in reducing risk; as such, lack of pancreatic stenting in high‐risk cases (OR 1.4–3.2) [9, 23–25] and lack of rectal NSAID prophylaxis [44] are associated with increased risk. Other medications have been investigated to reduce risk of PEP such as topical epinephrine and intravenous steroids; however, none have borne out as effectively as rectal indomethacin [45]. Systematic documentation of use of these agents in procedural notes should also be standard of care. It is notable that biliary sphincterotomy does not appear to independently increase the risk of pancreatitis. It also appears that precut or needle‐knife sphincterotomy likely does not add risk beyond that of the difficulty of cannulation itself; in fact, early precut may even reduce risk, as compared to conventional persistence, according to a meta‐analyses of

Table 6.1  Predictors of Adverse Events after ERCP. Adverse Event

Modifying Factor

Risk Magnitude (OR)

Reference(s)

Comment(s)

Infection

Liver transplant

5.2

[5]

Very rare (0.25–0.5%) (risk decreasing with time: OR 0.9/yr)

[6, 7]

Fistulas, non‐drainable ducts (e.g. hilar, intrahepatic strictures) Ductoscopy

Bleeding (Delayed)

Perforation

Jaundice

1.4

[8]

Small center

1.4

[8]

Sphincterotomy

4.7

[9]

Small center

1.1

[8]

Intraprocedural bleeding†

1.7

[12]

Coagulopathy†

3.3

[12]

Anticoagulation within 3 days†

5.1

[12]

Cholangitis†

2.6

[12]

Small‐volume endoscopies†

2.2 (1 or fewer per week)

[12]

Postsurgical anatomy

2.5

[8, 9]

Precut sphincterotomy

2.0

[8]

Intramural contrast

1.9

[8]

Sphincterotomy

Very rare; can also occur with large balloon sphincteroplasty No increased risk with antiplatelets, especially aspirin monotherapy [10, 11]

Defined as >2 sec prothrombin time, hemodialysis, or platelet count 2.2%/year) [52, 56]. Considering balloon sphincteroplasty or temporary stenting in patients who cannot come off anticoagulation is a reasonable approach. Of note, cholestasis or jaundice, malnutrition, antibiotic therapy, and pancreatic insufficiency are all risk factors for (occult) vitamin K deficiency. Therefore, although a preprocedural INR for all‐comers for ERCP is not suggested, selective preprocedural INR in these high‐risk groups (ideally 1 day before to allow time for vitamin K to take effect) is important. Patients with concomitant liver disease should also get a platelet count and an INR, although the INR may not be predictive of their bleeding risk [57, 58]. In addition, however, patients with liver disease, because of increased portal pressures and duodenal venous congestion, may be at mildly higher risk for bleeding after sphincterotomy, independent of their INR. Aspirin monotherapy does not need to be stopped, but dual therapy should likely be adjusted to monotherapy when safe. ASGE guidelines suggest discontinuing nonaspirin antiplatelet drugs in patients at low risk for thromboembolism [53]. Thrombosis of a coronary stent after stopping antiplatelet drugs is recognized to occur after noncardiac surgery [10, 11, 12, 51], especially in patients with high‐risk coronary anatomy (i.e. within 6 weeks of placing a bare metal stent and within 1 year with drug‐eluting stents [10]). The type of stent and the time since its insertion need to be included in risk assessment. Guidelines regarding how long to hold antiplatelets are usually based on the fact that irreversible antiplatelet drugs generally require 7–9 days of cessation to allow full marrow replenishment with new normal platelets [53, 59]. However, by 5 days, most platelet

6  Risk Assessment and Reduction

f­ unction has returned, and so, this is generally considered good enough to allow even major surgery. After bypass surgery, bleeding outcomes for aspirin‐clopidogrel dual therapy stopped 5 days prior and aspirin monotherapy were comparable, but were 1.5 times higher if clopidogrel was taken within 5 days of surgery [60]. Because cardiac mortality can increase with as little as 7 days of antiplatelet cessation in the context of gastrointestinal bleeding [61], holding for only 5 days may be a better balance of risks and benefits. The ideal time to resume antiplatelet dual therapy after sphincterotomy is not known [53]. Having an adequate volume of case, for the endoscopist and team, and making sure that they are comfortable with what to do with intraprocedural bleeding, are both important. Lastly, certain rescue techniques (e.g. precut) will not be available in patients who are left on anticoagulation or dual antiplatelet therapy because they were not anticipated to “need” a sphincterotomy.

Infection Infection is rare after ERCP. It is reported to be more likely in patients who have undergone liver transplant (OR 5.2) [5] hilar/intrahepatic strictures (e.g. Klatskin‐type tumors or primary sclerosing cholangitis [PSC]) [6, 62], and in small volume centers (OR 1.4) [8]. It also appears higher in (obstructive) jaundice (OR 1.4) [8], although it is questionable whether this risk still applies when the obstruction is relieved successfully by the procedure. Increasing intraductal pressure should be avoided by aspirating bile and limiting the volume of contrast injected. This is particularly a concern for patients who have already had colonization of their bile via prior manipulation of their ducts via stents or sphincterotomy. Although contrast agents are delivered sterile, they are injected through a catheter that touches the scope tip, which has been through the patient’s mouth. Therefore, even in patients without prior duct contamination or colonization, procedures that involve contrast entering non‐drainable sterile body cavities (e.g. the peritoneum, in the case of leaks or fistulae) have a higher risk of infection. Based on this, prophylactic antibiotics should be given to patients anticipated to have non‐drainable (or difficult to drain) obstructed duct segments (PSC, hilar tumors, selected patients with chronic pancreatitis stricture), cases of pseudocyst and bile leak, and patients having a liver transplant. Unanticipated cases of patients with infection risk (e.g. failed stone extraction) should start antibiotics as quickly as possible, preferably during the procedure. Antibiotics are not generally recommended before ERCP in all patients who are jaundiced, although some endoscopists still choose to do this. In the last several years, concern for duodenoscope‐associated infections has come to light, notably in regard to carbapenem‐resistant Enterobacteriaceae (CRE). Suggested interventions include enhancing disinfection processes, use of gas sterilization with ethylene oxide, and even developing single‐use duodenoscopes [48]. These issues are described in detail in Chapter 4.

Perforation Perforation is rare. It comes in two forms – scope‐induced (big hole) or accessory‐induced (small hole). In multivariate analyses, scope‐related luminal perforation has been ­associated

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ERCP: The Fundamentals

with surgically altered anatomy (OR 2.5), likely as a result of the long length of scope needed, tortuous anatomy, and adhesions [8, 9]. Perhaps with the advent of newer techniques for papillary access in altered anatomy patients such as endoscopic ultrasound (EUS)‐directed transgastric ERCP, the overall number of perforations related to the use of enteroscopes will decrease. Sphincterotomy accounts for most accessory‐type perforations, and precut (OR 2.0) has higher risk than conventional sphincterotomy [8]. If these are ­recognized during the procedure, a temporary stent may help seal the hole and wick ­secretions away from the opening. Intramural contrast injection (OR 1.9) was found to increase risk, although this may just be a marker of a difficult cannulation and considerable accessory manipulation of the duct and ampulla [8]. Rare ductal perforations have been associated with biopsies, ablations, or scopes within the ducts. Submucosal or transmural tracking of guidewires is technically a small perforation but is generally well‐tolerated (usually not reaching the definition of an adverse event), with or without a stent or antibiotics. Avoiding excessive manipulation, care in sphincterotomy technique (especially for precut), and appropriate consent of patients with altered anatomy undergoing ERCP (and knowing when to stop in these cases when scope advancement is not progressing) are ways to integrate this information into practice to reduce this risk.

Cardiopulmonary Events The role of risk factors and risk modification of cardiopulmonary events has been detailed elsewhere [3]. Briefly, much of the literature on preoperative evaluation applies to surgical settings. Some do not apply very well to endoscopy. Case Context and Comorbidity Quantification

Age [7], American Society of Anesthesiologists) ASA score (physiologic classification) [7, 28], type of anesthesia [28, 30–51], inpatient status [7], non‐university hospital [7], and trainee involvement [7, 34] are among the risk factors identified in the endoscopy literature (mostly colonoscopy), with ASA score being the most powerful predictor [7, 28, 41]. In addition, a number of scoring systems were developed to help adjust for confounding related to comorbidities, mainly in surgery [3]. Although these comorbidity scoring ­systems are not practical for daily use, the elements they identify give a perspective on the ­important factors. Acute Physiology And Chronic Health Evaluation (APACHE‐II) scores, cardiopulmonary disease, and recent MI specifically, may also predict adverse events [27, 29, 35–38]; APACHE‐II is a complex instrument, with dimensions that include a physiology score (12 inputs), an age score, and organ‐failure points, with a number of elements (e.g. partial pressure of oxygen [PaO2] and arterial pH) that are not available for most endoscopies. Sleep apnea and body mass index (BMI) may be important. However, for moderate sedation in left lateral position, unrecognized sleep apnea [63] did not appear to predict transient hypoxia or adverse events in one routine endoscopy study [36]; another study found that BMI in patients scored as ASA I‐II predicted the number of hypoxemic episodes [42]. Increased BMI and obstructive sleep apnea can predict perioperative morbidity after surgery [64] and may increase risk and make airway maintenance more difficulty in deep

6  Risk Assessment and Reduction

sedation [41],especially for the semi‐prone positioning that is standard for ERCP. Intubating a patient who is semi‐prone because of these upper airway issues or on an X‐ray table is cumbersome. It generally requires “flipping” the patient on to a stretcher into a supine position for intubation and then rolling him or her back on to the X‐ray table once intubated to complete the procedure. Despite this theoretical concern, deep sedation, without intubation, has been shown to be safe in ERCP in a meta‐analysis of randomized trials [65]. Despite this literature, anesthesia practice in many centers increasingly involves universal intubation for all patients undergoing ERCP sedated with propofol, unless the patient is in the left‐lateral position, the BMI is reasonable, and the ERCP is anticipated to be quick and easy. A variety of other scoring systems exist. The Charlson Comorbidity Index [19] is simply a weighted list of 19 comorbidities created to predict life expectancy over months or years. It is not helpful in predicting events in the short term (e.g. 30 days). The [26, 46, 47] Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) score has both graded physiologic and operative elements predicting surgical morbidity and mortality, but it is cumbersome to calculate a score manually (online calculator is available), and most of the elements (peritoneal soiling, etc.) do not pertain to endoscopy. The National Surgical Quality Improvement Program (NSQIP) is a registry of multiple preoperative risk factors, laboratory data, operative procedure details, ASA, Mallampati score, wound class, and postoperative events. The first section’s data entry is quite labor intensive, with >30 yes‐or‐no questions. However, the 20 factors felt to be most important (in roughly decreasing predictive importance) might be helpful in assessing anesthesia risk in ERCP. These include functional status (i.e. dependence [partial/total], dyspnea [resting/exertional], altered sensorium, morbid obesity), prior cardiac intervention, current smoking, stroke, hypertension, diabetes, chronic obstructive pulmonary ­disease (COPD), age, and hypoalbuminemia. Cardiac Risk Assessment

There are a few risk‐assessment tools for cardiac risk in noncardiac surgery, including Goldman’s [39] and Detsky’s [40]. The former had nine independent predictors of outcome: active heart failure and MI (within 6 months) were most powerful, followed by arrhythmias, age (>70), surgery type, and poor overall/“functional” status (i.e. hypoxia, hypercarbia, hypokalemia, low bicarbonate, creatinine >2.5× normal, liver disease, or bed‐ ridden). A modified version, including male gender and propofol use, predicted cardiac adverse events after endoscopy [66]. Detsky’s score [40] is fairly simple and includes recent (inactive) heart failure, prior infarction, and the Canadian Cardiovascular Society Classification of Angina. Guidelines for perioperative cardiovascular evaluation for noncardiac surgery were updated in 2002 [67] and include many of the preceding features, plus valvular disease, diabetes, stroke, and diastolic pressure >100 mm Hg, with recent infarction or active heart failure considered most important. Poor functional status was more precisely defined in metabolic equivalents (METS) [67, 68]. In the United States, the Joint Commission emphasizes recording the continuation of beta‐blockers for procedures involving an anesthesia team. However, this recommendation is based on a reduction in perioperative mortality in major abdominal, orthopedic, and vascular surgery and not in endoscopy [69]. In addition, a larger meta‐analysis of various

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surgery types did not agree with the reduction in risk [70]. Patients generally are told to take their cardiac medicines with sips of water before ERCP anyway. Regardless, the extrapolation of its importance to endoscopy does not seem evidence‐based, despite being required in the Joint Commission’s “time‐out” checklist and recorded as a National Quality Forum (NQF)‐endorsed unit quality measure. The factors that come up most often in the context of cardiopulmonary risk and appear most important include age, prior and recent MI, prior or current/recent heart failure, arrhythmia, diabetes, renal failure, uncontrolled hypertension, prior stroke or other neurologic impairment, and inability to do a 4–6 METS activity (e.g. walk up a flight of stairs, do yard work, golf without a cart, or walk >4 mph). Other factors such as sleep apnea, obesity, polypharmacy, severe COPD and use of home oxygen, procedure duration, and depth of sedation also likely modify cardiopulmonary risk in endoscopy and deserve further study. These factors should be taken into consideration when considering ERCP, especially in cases with weaker indications in high‐risk subjects. Although some of these factors are not modifiable, controlling hypertension, waiting 4–6 weeks after MI or heart failure admissions, correcting valve pathology, and improving functional status will likely decrease the cardiopulmonary risk after ERCP and should all be considered when feasible. Fostering good relationships with anesthesia and ­promoting preoperative clinic evaluation when necessary is paramount.

Failure of Cannulation Failure of cannulation is not a traditional “risk” but is an important adverse event because it may lead to downstream rescue procedures with their attendant risks. In addition, endoscopists, units, or patient groups with higher failure rates generally have higher rates of other adverse events because of cannulation difficulties. Recently, we used a subset of the multicenter ERCP quality network, comprising more than 10,000 ERCPs performed by over 80 endoscopists to assess for associations with cannulation failure [69]. Conventional (i.e. without precut assistance) success was more likely in outpatients (OR 1.21) but less likely in complex contexts (OR 0.59), sicker patients (ASA grade [II, III/V: OR 0.81, 0.77]), teaching cases (OR 0.53), and certain indications (e.g. strictures, active pancreatitis). Overall cannulation success (i.e. including some that were precut‐assisted) was more likely with higher volume endoscopists (>239/year: OR 2.79), more efficient fluoroscopy practices (OR 1.72), and was lower with moderate (compared with deeper) sedation (OR 0.67) [27].

Radiation Exposure and Contrast Allergy Using an eligible subset of the ERCP quality network database, comprising >9000 procedures performed by more than 50 endoscopists, the 90th percentile for providers for fluoroscopy time was found to be 10 minutes (and 22% of total procedure time); 14 minutes (mean plus two standard deviation) was defined as excessive [66]. Every sequential group of 50 cases entered in the registry was associated with lower fluoroscopy time (by 0.2 min; P = 0.001) raising the possibility that simply tracking one’s own times helps lower them. In addition, multivariate analysis revealed lower lifetime (3× upper limit of normal, type II is pain with either dilated ducts or abnormal enzymes elevation during an attack, and type III is pain only without evidence of dilated duct or documented abnormal enzymes level. Depending on the type of symptoms referable to the biliary or pancreatic system, the management is by performing a sphincterotomy. For type I, there is an expected 75% improvement and 50% for type II; but recent a randomized controlled trial showed that sphincterotomy is not effective for the management of type III cases  [16], leading to the general belief that type III SOD does not exist, and in the absence of objective evidence, other causes of abdominal pain should be ruled out. These issues are expanded in Chapter 20. Manometric studies of the biliary and pancreatic sphincters have been performed during ERCP to establish overactivity and became quite popular, but the evidence that the results predict the outcome of sphincterotomy is weak, and few centers now use manometry. Measurement of the pressure can be done with two types of pressure measurement system. Both require the initial placement of an 0.018″ guidewire into the respective duct. The pressure in the duodenum is recorded and adjusted to zero prior to inserting the manometry catheter into the bile or pancreatic duct. The traditional method uses a special catheter where water is perfused through two side holes for pressure measurement, while aspiration to remove the infused water is done through the middle port to minimize the risk of excess infused fluid causing pancreatitis. The pressure is recorded as the catheter is withdrawn through the sphincter. There are visual markers that indicate the position of the transducer in relation to the sphincter for proper pressure measurement. The pressure at each location is recorded for at least 15 seconds to obtain several contraction waves, which indicate

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proper positioning of the transducer in the sphincter region for pressure measurement. The pressure tracing should return to zero when the catheter or transducer is withdrawn into the duodenum. Compared with the duodenal pressure, a basal sphincter pressure of above 40 mm Hg is considered significant. An alternative method is to use a solid‐state pressure transducer built in at the tip of the manometry catheter inserted over the guidewire.

­Endoscopic Management of Bile Leaks The problem of postsurgical bile leaks is discussed in Chapter  15. They can usually be treated effectively by endoscopic stenting, sphincterotomy, or a combination. Sphincterotomy can usually be avoided (with its associated risks) because small leaks from the cystic duct usually resolve with placement of a nasobiliary catheter or stenting (with a short stent just across the papilla) for a few days. A leak associated with a duct injury may require placement of a stent across the leak for up to 4–6 weeks, and it is important to check for residual damage or stricture in the bile duct after removal of the stent, which may require further treatment.

­Conclusion In this section, we have discussed the different techniques and equipment used for ERCP in the management of patients with many underlying pancreatic and biliary pathologies. The most important issue is to recognize the respective axis of the ductal systems and understand the limitations with each technique to ensure a safe procedure. When these various techniques are best used (and avoided) is discussed in the relevant clinical chapters.

­References 1 Cotton PB, Williams C. Practical Gastrointestinal Endoscopy, 4th ed. Oxford: Blackwell Science; 1996. 2 Leung JWC. Fundamentals of ERCP. In: Cotton and Leung, eds., Advanced Digestive Endoscopy: ERCP, 17–81. Malden, MA: Blackwell Publishing; 2005. 3 Lim B, Leung J. Wire for hire: the impact of wire‐guided cannulation in ERCP. Gastrointest Endosc 2009;69:450–452. 4 Leung JWC, Leung FW. Papillotomy performance scoring scale—a pilot validation study focused on the cut axis. Aliment Pharmac Ther 2006;24:308–312. 5 Leung JWC, Banez VP, Chung SCS. Precut (needle knife) papillotomy for impacted common bile duct stone at the ampulla. Am J Gastroenterol 1990;85:991–993. 6 Liao WC, Lee CT, Chang CY, et al. Randomized trial of 1‐minute versus 5‐minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc 2010;72:1154–1162.

8  Standard Devices and Techniques

7 Meng W, Leung JW, Zhang K, et al. Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single‐ blinded, randomised controlled trial [e‐pub ahead of print]. Lancet Gastroenterol Hepatol. 2019 Apr 16. pii: S2468‐1253(19)30075‐5. doi: 10.1016/S2468‐1253(19)30075‐5. 8 Ngo C, Leung JWC. Stone extraction. In: Baron and Carr‐Locke, eds., ERCP, 2nd ed., 152–165. Philadelphia, PA: Elsevier; 2013. 9 Leung JWC, Neuhaus H, Chopita N. Mechanical lithotripsy in the common bile duct. Endoscopy 2001;33(9):800–804. 10 Lee JG, Leung JWC. Tissue sampling at ERCP in suspected pancreatic cancer. Gastrointest Endosc Clin N Am 1998;8:221–235. 11 Leung JWC, Cotton PB. Endoscopic nasobiliary catheter drainage in biliary and pancreatic disease. Am J Gastroenterol 1991;86:389–394. 12 Leung JWC, Chung SCS, Sung JY, et al. Urgent endoscopic drainage for acute suppurative cholangitis. Lancet 1989;1:1307–1309. 13 Libby E, Leung JWC. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol 1996;91:1301–1308. 14 Leung JWC. Whenever I place a stent for a stone impacted bile duct or for bile leak, the stent always seem to shift position distally, should I use a shorter stent or a pigtail stent? Is there a trick to keep these stent in place? In: Leung and Lo, eds., Curbside Consultation in Endoscopy, 139–141. Thorofare, NJ: Slack Inc.; 2008. 15 Tarnasky PR, Cotton PB, Baillie J, et al. Proximal migration of biliary stents: attempted endoscopic retrieval in forty‐one patients. Gastrointest Endosc 1995;42:513–519. 16 Cotton PB, Durkalski V, Romagnuolo J, et al. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain‐related disability following cholecystectomy ‐ the EPISOD randomized clinical trial. JAMA 2014;311:2101–2109.

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9 When Standard Cannulation Approaches Fail Sundeep Lakhtakia1 and Shyam Varadarajulu2 1 2

Asian Institute of Gastroenterology, Hyderabad, India Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA

Key Points ●●

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Selective cannulation is almost always achievable by experts using standard methods in patients with normal anatomy and no major pathology in the region of the papilla. When difficulties arise, deep biliary cannulation is best attempted using double‐ guidewire and needle‐knife techniques (best over a pancreatic stent). Rendezvous approaches allow ERCP after a guidewire has been passed antegradely through the papilla via the transhepatic route, or with endoscopic ultrasound (EUS). Patients with surgically altered biliary anatomy are increasingly common and pose the greatest challenges. Balloon‐assisted enteroscopy, laparoscopy, or EUS guidance may be required to access the biliary system. Advanced techniques carry significant risks and must be undertaken only by those who possess requisite training and adequate technical resources.

­Principles of Biliary Access The principle of selective biliary cannulation is akin to a skilled firefighter (endoscopist) who has to enter a building (bile duct) to evacuate trapped residents (obstructive pathology). Unlocking the latches at the entry gate (standard cannulation) should be the first attempt to enter the building without bothering the neighbor (pancreas). Trying to break in (traumatic cannulation attempts) or repeated knocking at the neighbor’s door (pancreatic injections) can complicate the situation (post‐ERCP pancreatitis). If the neighbor’s (pancreas) gate opens first, it is prudent to evacuate him (prophylactic pancreatic duct stent) to limit damage. Once successful entry is gained into the building (selective bile duct cannulation) the doors can be opened (sphincterotomy) to enable entry of fire extinguishers (accessories) to facilitate the exit of trapped residents (obstructed bile). If entry from the main gate to the building is not possible, a drill can be used to make a window (precut or endoscopic ­ultrasound [EUS]‐guided common bile duct access). ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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If this fails, attempts to enter from the rear (percutaneous or EUS‐guided transhepatic rendezvous) to help open the main gate (major papilla) or exit from rear gate itself (e.g. hepaticogastrostomy, choledochoduodenostomy, or percutaneous drainage catheter) may be required. Key Points ●●

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Planning the cannulation technique: If it appears that standard biliary cannulation will be difficult, have a plan for the next method to use to gain access. Cannulation hierarchy is guided by papillary and duodenal anatomy, proceduralist skill set, and availability of ERCP accessories. As a general rule, the lowest risk and most familiar cannulation technique should be used first. When ERCP cannulation fails: Consider rescheduling the procedure for a second attempt after 24 to 48 hours to allow time for the ampullary edema to subside, which can help identify the ampullary and ductal tissue planes. Consider asking a colleague for assistance during the initial or subsequent procedure. Consider a combined ­procedure with EUS or percutaneous transhepatic cholangiography (PTC) guidance.

­ lacement of Double Guidewire or Pancreatic Stent P to Facilitate Biliary Access Inadvertent and repeated cannulation of the pancreatic duct (PD) can be frustrating if the duct of choice is the common bile duct (CBD). In such situations, passing a pancreatic guidewire or placing a pancreatic stent may facilitate biliary wire‐guided cannulation [1]. The double‐ guidewire technique involves placing a wire in the PD, then passing the cannula or sphincterotome with biliary guidewire down the working channel, beside the pancreatic wire. The tip of the cannula or sphincterotome is aimed toward the superior lip of the papillary orifice, directed toward 11 o’clock. The pancreatic guidewire stabilizes and lifts the papilla toward the working channel, straightens the PD and common channel, and orients the biliary opening for selective access. It can also be used to place a prophylactic pancreatic stent, either before or after successful biliary cannulation. This technique is particularly useful in patients with surgically altered anatomy or a tortuous common channel. Negotiating the pancreatic guidewire through to the pancreatic body or tail can be challenging because it may repeatedly enter the ductal side branches, with a resultant risk of pancreatic duct perforation and pancreatitis. Anatomical variations such as a tortuous duct, complete or incomplete pancreas divisum, and ansa pancreatica, can increase the difficulty. In these cases, using a thinner (0.018″) or nitinol‐ tipped wire may assist. Flipping the tip over may facilitate deep penetration.

­Precut or Access Sphincterotomy Key Points ●● ●●

Precut technique allows biliary access after failed initial cannulation. The margin for error is much smaller when performing precut sphincterotomy than for standard sphincterotomy. Training should begin with observation of multiple precut ­procedures and progress to hands‐on training when proficient at standard cannulation.

9  When Standard Cannulation Approaches Fail

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Precut is associated with a higher risk of complications [2, 3]. Precut is most commonly performed with a needle‐knife in a “below upward” direction, starting from the papillary orifice and cutting upward in layer‐by‐layer fashion. Fistulotomy or “above downward” needle‐knife sphincterotomy is another useful access technique. If a precut is performed, placement of a prophylactic PD stent reduces the chances of post‐ERCP pancreatitis (PEP).

Precut sphincterotomy (papillotomy) technique refers to gaining access to the bile duct by deroofing the duodenal portion of the ampulla and incising the terminal bile duct. Precut is the most commonly used technique after conventional methods fail [4]. Precut is usually followed by conventional sphincterotomy to complete planned therapy such as stone extraction or stent placement. The decision to perform a precut depends on the indication for ERCP, “comfort level” of the endoscopist, and anatomical orientation of the papilla. Precut sphincterotomy is usually performed using a needle‐knife catheter or occasionally with a traction papillotome.

Procedural Techniques Freehand needle‐knife sphincterotomy (NKS): The papilla can be incised either from “below‐upward” starting from the papillary orifice and cutting up toward the 11 o’clock direction, or approaching “above‐downward,” starting from the junction of upper one‐ third and lower two‐thirds of the ampullary mound and cutting down toward the papilla. Most ERCP experts prefer the “below upward” approach. The device is opened to expose 2–4 mm of the cutting wire. The needle‐knife movements have to be precise, cutting in 1‐ to 2‐mm longitudinal increments, with the intention of cutting the papilla down to the bile duct layer by layer. ●●

“Below‐upward” freehand NKS

The needle‐knife tip is placed at superior aspect of papillary orifice in the 11–12 o’clock position, and the tissue is slightly tented in the direction of the planned cut. The cut is extended upward along the ampullary mound in the 11–12 o’clock direction. The direction is controlled by either an upward motion with the large wheel and gentle leftward torsion or by an upward sweeping motion of the elevator. The aim is to deroof the papillary mound in a ­controlled, stepwise, fashion within one to three passes. The depth of the incision should be periodically checked by separating the cut edges with air or carbon dioxide insufflation, saline irrigation through the needle‐knife catheter, or by using the blunt end of the closed catheter. The proximal extent of the cut is determined by the intraduodenal bile duct and must stop short of the upper margin of the ampullary mound. The intramural bile duct is seen as yellowish‐white longitudinal muscular tissue. On further incision of the bile duct wall and with gentle suction, a speck of yellow tinged bile is often visualized, especially if the lower bile duct is not tightly obstructed. The bile duct is then selectively cannulated using a soft guidewire either through the needle‐knife or standard sphincterotome. Direct contrast

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injection from a distally impacted cannula should be avoided because of the risk of intramural extravasation within the divided tissue planes. Once the guidewire is passed into the ­biliary system, the sphincterotomy can be undertaken in the standard manner. ●●

“Above‐downward” freehand NKS

The needle is positioned at the junction of upper third and the lower two thirds of the ampullary mound. The incision generally starts in the 11 o’clock position and extends down toward 5 o’clock, stopping short of the papillary orifice. The technique of incising the ampullary mound and not extending to the papillary orifice is also termed a fistulotomy. Maintaining an inward thrust on the needle‐knife catheter while cutting exerts enough pressure on the surface of the ampulla to stretch it and achieve an appropriate depth of incision. A downward motion with the large wheel of the duodenoscope and scope torsion controls the direction and the depth of cut. The correct tissue plane is generally entered with two to three incisions. The potential advantages of this method are reduction in the perforation risk as the upper extent of the cut is predefined, and reduction in the risk of pancreatitis because the pancreatic orifice remains untouched. This technique is useful in cases with an impacted ampullary stone or any papillary orifice obstruction with bulging infundibulum of intramural CBD. Suprapapillary Fistulotomy/Infundibulotomy: This technique is only used in patients with a dilated bile duct causing a distinct impression on the duodenal wall and is generally above the occluded papillary orifice. A small opening is made into the intraduodenal segment of CBD, using a few “stabs” of short duration with a needle‐knife, in the Endocut or blended current mode. The point of entry is 3–5 mm superior to the papillary orifice measured visually on the vertical axis (Figure 9.1). A spot of bile is often seen after incising the mucosa, and the opening is then probed with a cannula and guidewire to create a choledochoduodenal fistula. This technique should be avoided in patients with altered anatomy. Over‐the‐Stent NKS: Over‐the‐stent NKS is a technique in which the needle‐knife precut is performed after PD stent placement, typically after repeated inadvertent PD cannulation (Figure 9.2). The PD stent protects the pancreatic orifice and reduces the chance of PEP [5], as well as straightening the intramural ampullary segment to facilitate passage of a guidewire into the CBD. The PD orifice is generally oriented in the 5 o’clock position, and the stent also serves as a landmark to help localize the biliary orifice, which is generally in the 11 o’clock position.

Less Common Precut Techniques ●●

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Traction papillotome technique: This technique (also referred to as “papillary roof incision”) was originally described using a specialized short‐nosed papillotome. The papillotome is wedged into the common channel, and the incision is made in the direction of the bile duct without wire guidance [6]. Transpancreatic precut sphincterotomy: The tip of a standard sphincterotome is intentionally inserted into the pancreatic duct (Figure 9.3). Incision is made in the direction of the bile duct, through the septum dividing the biliary and pancreatic ducts [7]. If feasible, a prophylactic pancreatic stent should be placed because there is a significant risk of PEP. There are also potential long‐term consequences of a pancreatic sphincterotomy, such as pancreatic orifice stenosis [8].

9  When Standard Cannulation Approaches Fail

Figure 9.1  Fistulotomy is performed by creating a point of entry 3–5 mm superior to the papillary orifice in the orientation of the bile duct to gain biliary access.

Figure 9.2  Biliary access is gained by performing precut over a pancreatic duct stent using a needle knife.

Figure 9.3  After cannulating the pancreatic duct, the sphincterotome is oriented toward the bile duct, and an incision is made via the septum to gain biliary access.

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Intramural incision technique: This technique uses the false tract that can be created by the guidewire during biliary cannulation attempts. The sphincterotome is positioned in the false track at the intramural portion of the papilla and the biliary orifice is unroofed from the inside to out [9]. Endoscopic ampullectomy has been reported as a technique for biliary access when other methods have failed in a select group of patients [10].

Precut Complications The main complications include pancreatitis, perforation, and bleeding. It is often argued whether the complications of precut are due to the precut itself or to the preceding multiple failed cannulation attempts. A prospective, randomized multicenter study showed the pancreatitis risk was lower with early precut compared with persisting with cannulation attempts then performing a late precut [11]. A meta‐analysis showed that conventional precut sphincterotomy without a pancreatic stent was a significant risk for PEP even after adjusting for other variables [12]. Prophylactic pancreatic duct stent placement should always be considered.

Precut Learning Curve Three studies [13–15] involving 603 patients have evaluated the learning curve for performing precut sphincterotomy (Table 9.1). Although two studies did not demonstrate a learning curve to achieve proficiency [13, 14], in one study the success rates improved from 88% to 98% with time [15]. Also, while there was no difference in rates of complications in two studies [14, 15], in one study the complication rate decreased from 28% to 7% with time [13].

­Intradiverticular Papilla Cannulation of the ampulla inside a diverticulum can be challenging. The ampulla is most commonly on the rim of the diverticulum but can be located anywhere within. The duodenoscope and sphincterotome should be aligned with the direction of the Table 9.1  Precut sphincterotomy learning curve. Author (Ref)

No.

Initial success

Final success

Complications

Learning curve

Akaraviputh [13]

200

88%

82%

28% to 7%

Tech: No Complications: Yes

Harewood [15]

253

88%

98%

12% to 14%

Tech: Yes Complications: No

Robison [14]

150

84%

92%

7%

No (after 200)

9  When Standard Cannulation Approaches Fail

i­ ntradiverticular ampullary mound, which may require significant right‐to‐left movements with the small wheel and scope torsion. Avoid excess gas insufflation because this will distend the diverticulum pulling the orifice away and increasing the difficulty in cannulation. Often the ampulla can be exposed by “pulling” the surrounding tissue out from the diverticulum and into the duodenal lumen using the tip of the sphincterotome. The sphincterotome can be reshaped so it exits the working channel at a different angle, or a rotatable sphincterotome can be used. Other methods to improve access to the papilla include using a pediatric biopsy forceps alongside the sphincterotome, injection of saline inside the diverticulum, or endoscopically clipping the redundant mucosa along the rim (Figure 9.4a–c).

(a)

(b)

(c)

Figure 9.4  Intradiverticular papilla: The papilla was located within a deep duodenal diverticulum (a). Mucosa was “pulled” from the diverticulum and clipped with a hemostatic clip to improve access to the papilla (b). This allowed deep biliary cannulation with a sphincterotome (c) and successful endotherapy.

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­Altered Surgical Anatomy Key Points ●●

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Commonly encountered altered surgical anatomy includes Billroth II gastrectomy, Roux‐en‐Y gastrojejunostomy (RYGJ), and Roux‐en‐Y gastric bypass (RYGB). Challenges are both in reaching the papilla and subsequent biliary cannulation. Because of the retrograde approach, the orientation of major papilla is rotated by 180°. In Billroth II anatomy, either a forward‐viewing endoscope or a duodenoscope can be used to reach the papilla. In RYGJ or hepaticojejunostomy, a pediatric colonoscope or balloon‐assisted enteroscope may be used. In RYGB with long Roux and afferent limbs with intact antro‐duodenal path, laparoscope‐assisted ERCP or ERCP through a gastrostomy tube are options.

Patients with altered surgical anatomy pose a challenge at ERCP in gaining endoscopic access to the papilla and to the challenge of biliary cannulation. After reaching the papilla, the cannulation success rate approaches that seen in patients with normal anatomy [16]. Billroth II procedures are becoming less common as the effectiveness of medical treatment for peptic ulcer disease has increased. In contrast, Roux en Y anatomy is becoming more common because of its increased use as a bariatric surgery technique [17]. One of the main complications seen when performing ERCP in patients with altered surgical anatomy is luminal perforation. This usually occurs at surgical anastomoses or tight angulations of the intestine during scope insertion.

Reaching the Papilla Billroth II anatomy: The papilla can be reached using a duodenoscope or enteroscope in most cases as the afferent limb is relatively short. The afferent limb typically is located along the lesser curve, while the efferent limb is along the greater curve. If the scope is looping within the stomach, abdominal compression, supine positioning, or placing a ­polypectomy snare in the endoscope working channel to serve as a stiffening device can assist. If the papilla cannot be initially reached with the duodenoscope, a forward‐viewing scope can be passed first to mark the correct limb by taking a biopsy or to place a stiff guidewire in the afferent limb for subsequent “back‐loading” and duodenoscope advancement. Once the papilla is reached, the duodenoscope assumes a “hockey stick” configuration on fluoroscopy (Figure 9.5). Roux en Y anatomy: Although a duodenoscope is advantageous for biliary cannulation, a pediatric colonoscope, enteroscope, or balloon‐assisted enteroscope is generally preferred for Roux‐en‐Y anatomy. In patients with RYGJ or Roux‐en‐Y hepaticojejunostomy (RYHJ) anatomy, a duodenoscope typically lacks the length and maneuverability needed to navigate the Roux limb to reach the papilla or hepaticojejunostomy. In gastro‐enterostomies with Roux‐ en‐Y reconstruction, at the Roux anastomosis, the Roux limb is usually identified as the more proximal lumen with sharp angle of entry. Careful negotiation with gentle scope torque, slight scope withdrawal and use of the wheels is required because this is ­usually the most challenging point of intubation and has the highest risk of luminal perforation. On fluoroscopy, as the scope is advanced up the Roux limb toward the papilla, it approaches from the left abdomen

9  When Standard Cannulation Approaches Fail

or midline and moves toward the right upper quadrant (Figure 9.6). Movement away from the right upper quadrant on fluoroscopy indicates the Roux limb may not have been selected.

Cannulation Because the papilla is approached in a retrograde direction, the major papilla is located more proximally and to the right of the minor papilla. Orientation of the biliary and pancreatic ducts is reversed, with the pancreatic and biliary orifices usually found in the 11 o’clock and 5 o’clock positions, respectively. Figure 9.5  Billroth II ERCP fluoroscopy: The duodenoscope forms a “hockey stick” configuration on fluoroscopy in Billroth II anatomy. A pancreatic stent was placed after initial pancreatic duct cannulation. A biliary balloon sphincteroplasty was performed after biliary cannulation and a small needle‐knife sphincterotomy.

Figure 9.6  Roux en Y ERCP fluoroscopy: The double‐balloon enteroscope has a looped appearance with a Roux‐en‐Y ERCP (right panel) and biliary access is obtained for stone extraction (left panel).

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Biliary cannulation with a forward‐viewing endoscope is challenging with a success rate of only 70–80% [16]. Long accessories are required if a pediatric colonoscope or enteroscope is used. Selective biliary cannulation can be achieved by using a straight cannula, a wire‐guided Billroth II papillotomes (which has the cutting wire in the convex direction downward), or a rotatable papillotome [18] in conjunction with guidewires. If sphincterotomy is required, it is usually performed with a needle‐knife catheter over a biliary or pancreatic stent. Freehand NKS can be performed; however, it is challenging because of reduced scope tip control with altered anatomy, the lack of an elevator with colonoscopes and enteroscopes, and the altered papillary orientation. An increasingly popular method is to perform a small freehand NKS followed by a balloon sphincteroplasty. This is technically easier than sphincterotomy and has a similar complication rate [19]. Patients with RYGB differ from RYGJ and RYHJ reconstructions in two regards that are clinically relevant to the performance of biliary endoscopy. Firstly, the Roux jejunojejunostomy is often at a greater distance from the stomach, resulting in both longer alimentary (Roux) and biliopancreatic limbs, both adding to degree of difficulty in reaching the biliary orifice. There are mixed opinions on whether RYGB anatomy is associated with a lower rate of successful access to the biliary orifice compared to RYGJ or RYHJ, when balloon‐assisted enteroscopy is used. Secondly, the intact antro‐duodenal pathway to the biliary tree makes transgastric endoscopic approaches possible in patients with RYGB, which are not options in RYGJ and RYHJ. An option is the creation of a surgical or radiologic gastrostomy into the excluded stomach and subsequent access and dilation of the gastrostomy tract after allowing 3–4 weeks for tract maturation. Recently, EUS guidance has been used successfully to access the major duodenal papilla in patients with RYGB anatomy. Under sonographic visualization, the cautery‐enhanced delivery system is advanced from the gastric pouch into the excluded stomach and a 15‐ or 20‐mm lumen‐apposing metal stent (LAMS) is deployed. The duodenoscope is then carefully maneuvered via the stent lumen to access the major duodenal papilla to undertake requisite therapy (Figure  9.7). Once treatment is completed, the LAMS is removed and the fistula tends to seal with time. Alternatively, laparoscopy‐assisted ERCP involves the

Figure 9.7  A lumen-apposing metal stent (left panel) is placed via the remnant stomach to access the excluded stomach and a duodenoscope is passed via the stent lumen (arrow) to reach the major duodenal papilla to undertake biliary interventions (right panel).

9  When Standard Cannulation Approaches Fail

c­ reation of a laparoscopic gastrostomy and intraoperative passage of a duodenoscope via the newly created gastrostomy. The latter method has been associated with high (90–100%) success rates [12]. A gastrostomy tube can be placed after ERCP if repeat intervention is anticipated. Significant complications (up to 15%) have been reported with this technique, including perforation, leak, and wound infection at the gastrostomy site. Performing ERCP in patients with altered anatomy is categorized as the highest complexity procedure [20].

­Combined Procedures Key Points ●●

●● ●●

●●

●●

Combined procedures can be performed when ERCP fails, under PTC or EUS guidance. Should the need arise, a PTC can be converted to percutaneous biliary drainage. EUS‐guided biliary access can be performed via the transhepatic or transduodenal route. EUS‐guided antegrade drainage can be performed if the guidewire fails to pass across the papilla. Both PTC and EUS‐guided drainage procedures are associated with significant complications.

Biliary cannulation fails at ERCP in a small percentage of patients even in expert hands. In  such instances, “combined” or “rendezvous” procedures can be employed where a guidewire is routed antegrade through the biliary tract across the papilla into duodenum. The duodenoscope is then advanced, and the CBD is cannulated retrograde using the projecting guidewire. An important prerequisite for combined procedures is a dilated biliary ductal system.

Percutaneous Approach Traditionally, the percutaneous needle puncture is made into the peripheral right or left biliary system under transabdominal ultrasound and fluoroscopy guidance. After aspirating bile, a cholangiogram is obtained to provide a roadmap for guidewire passage. The guidewire is then passed via the PTC needle and negotiated across the papilla for subsequent ERCP. The current standard of care is to deploy an internal‐external catheter that is followed several days later by a therapeutic ERCP. At ERCP, a guidewire is passed through the PTC placed internal‐external catheter into the duodenal lumen. The guidewire tip is captured with a snare or forceps and gently retracted out of the duodenoscope in sync with external feeding of the guidewire from the percutaneous site. The PTC catheter is removed, leaving the wire passing from the PTC site, through the biliary system and out through the duodenoscope working channel. The most common complications encountered at PTC are sepsis, bile leak, and bleeding. In cases where the papilla is still not accessible at ERCP, therapeutic interventions such as metal stent placement or biliary stone extraction are

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undertaken via the percutaneous route. If temporary drainage is required, a pigtail catheter can be deployed over the guidewire (percutaneous transhepatic biliary drainage [PTBD]) after dilating the percutaneous tract. In rare instances, combined procedures can be performed with transpapillary guidewire passed via prior surgically placed T‐tubes or via the cystic duct during cholecystectomy to facilitate subsequent biliary ERCP.

EUS‐Guided Approach EUS is being increasingly used as an alternative to percutaneous techniques for accessing the biliary tract for combined procedures [21]. The major advantage of EUS‐guided biliary approach is that both guidewire passage and ERCP can be undertaken in the same session (Figure 9.8a–d). EUS can also be used for antegrade drainage if the guidewire fails to cross the papilla or if the papilla is endoscopically inaccessible (Figure 9.9a–d). EUS usually provides more than one option for biliary access, such as via the left lobe of the liver or the distal CBD. Whether the point of access is extra‐ or intrahepatic, there are three approaches to establishing biliary drainage. When the native papilla is endoscopically accessible, the preferred mode of drainage is by using the rendezvous technique. When the papilla is inaccessible, either antegrade stent placement or transluminal drainage (hepaticogastrostoomy or choledochoduodenostomy) is undertaken.

EUS-Guided Procedural Technique EUS‐guided biliary access is performed with the patient in the supine or prone position (not in lateral position) to adequately interpret the cholangiogram. It is mandatory to use carbon dioxide insufflation instead of air because perforation can occur during biliary puncture or tract dilation. Adequate and prolonged sedation, along with a patient endoscopist and staff is imperative to achieve technical success. The EUS‐guided approach is a multistep process: guidewire manipulation across the distal stricture and toward the ampulla, a need to exchange the echoendoscope for a duodenoscope, guidewire retraction followed by subsequent retrograde biliary cannulation, and finally undertaking the therapeutic intervention. Only endoscopists with skills in both EUS and ERCP should perform EUS‐guided biliary rendezvous or drainage procedures. EUS‐guided drainage should not be used to compensate for a lack of ERCP skills. The biliary tree is usually accessed via the proximal stomach (transgastric intrahepatic route) or the first part of duodenum (transduodenal extrahepatic route). The guidewire is manipulated antegrade through the native papilla for subsequent rendezvous ERCP. The accessory used for EUS‐guided bile duct puncture can either be a cautery‐based flexible device (6–10 Fr cystotome), which has a round cutting tip and a stable diathermic sheath, or the more commonly used 19‐gauge FNA needle. Doppler is employed to avoid puncturing intervening vessels. After ductal access, bile is aspirated to confirm position, and contrast is injected through the needle to obtain an adequate biliary “road map.” While a 0.035″ guidewire can be passed via a 19‐gauge needle, only a 0.018″ guidewire can be passed if a 22‐gauge needle is used to access the biliary system.

9  When Standard Cannulation Approaches Fail (a)

(b)

(c)

(d)

Figure 9.8  Endoscopic ultrasound (EUS)‐guided rendezvous: EUS‐guided rendezvous is performed by inserting a 19‐gauge fine‐needle aspiration (FNA) needle into the extrahepatic biliary system, through which a wire is passed and cholangiogram obtained (a). The wire is manipulated across the ampulla (b) and into the duodenum. The scope is then exchanged for a duodenoscope, and the wire at the ampulla is pulled through the working channel using forceps or a snare (c). The ERCP then proceeds in a standard manner (d)

Transduodenal drainage: The CBD is punctured with the echoendoscope in a long position, and the needle has a natural tendency to eject toward the liver hilum, which is the preferential direction for guidewire passage. Manipulating the guidewire within a stiff needle to negotiate its passage across the papilla is one of the most challenging maneuvers in EUS‐guided biliary drainage. There is a genuine risk for “shearing” the guidewire coating by the sharp beveled edge of the needle. To avoid shearing, newer 19‐gauge access needles with a blunt end and sharp stylet have been developed. Use of a hydrophilic angle‐tipped guidewire, sometimes of shorter length, helps to more accurately transmit the torque

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ERCP: The Fundamentals (a)

(c)

(b)

(d)

Figure 9.9  Choledochoduodenostomy: A choledochoduodenostomy was performed in a patient with a distally obstructing pancreatic tumor. A 19‐gauge needle gained transduodenal biliary access (a) and a cholangiogram was obtained (b). The transmural tract was dilated, and a fully covered self‐expanding metal stent inserted for biliary drainage (c). Endoscopic view of a fully covered biliary metal stent via the duodenal fistula (d).

movement to the tip to negotiate the bends and strictures inside the bile duct. If this maneuver fails, the transmural tract can be minimally dilated with a tapered tip bougie (cannula) or by using a thin caliber over‐the‐wire “fistulotome” (6 Fr) to enter the bile duct. Manipulating the guidewire with such an accessory inside the bile duct makes the further procedure comparatively easy. Transhepatic drainage: The intrahepatic radicle of the left lobe of the liver is punctured with the echoendoscope in a relatively straight position in the stomach. However, compared to transduodenal drainage, the guidewire has to traverse a longer and more tortuous intra‐ and extrahepatic course to exit the papilla. Hilar and proximal biliary strictures are particularly

9  When Standard Cannulation Approaches Fail

challenging to pass but can usually be achieved by dilating the puncture site by exchanging the EUS needle, over the wire, for a tapered bougie, wire‐guided needle‐knife or coaxial fistulotome. The aim is to drain the bile physiologically through the papilla into the duodenum, so all efforts must be made to negotiate the wire through the papilla. As a note of caution, if the transhepatic drainage is not completed, the patient is highly likely to develop a peritoneal bile leak. Furthermore, the dilated intrahepatic bile duct can rapidly collapse on initial puncture, and the subsequent contrast or bile extravasation can impair the endosonographic view making repeat puncture difficult. If the guidewire cannot be negotiated across the papilla or is obstructed proximally by a tight biliary stricture, a fully covered self‐expanding metal stent (fcSEMS) biliary stent should be deployed transmurally. The EUS rendezvous approach is preferred over EUS‐guided transmural drainage because it drains the bile physiologically and avoids the need for a permanent bilioenteric fistula that may require repeat dilations. It is prudent not to dilate the transluminal tract until satisfactory guidewire positioning has been obtained for stent placement. Procedure‐related complications include bile leak, peritonitis, cholecystitis, cholangitis, pancreatitis, fever, liver laceration, subcapsular liver hematoma, intraperitoneal stent migration, and retained sheared wire. Some of these complications can be avoided with the use of carbon dioxide insufflation and larger covered metal stents to seal the iatrogenic bilioenteric tracts to prevent bile leakage [22]. Outcomes of recent randomized trials suggest EUS‐guided biliary drainage is comparable to ERCP in patients with malignant obstructive jaundice [23].

How to Reduce Adverse Events in Patients Undergoing EUS-Guided Biliary Drainage? i)  Transmural fistula should not be created unless the guidewire is placed at a desired angle in the preferred ducts. Avoid aggressive balloon dilation of the fistulous tract. ii)  Transmural fistula must preferentially be created with the aid of graded‐dilation catheters or small‐caliber balloons. Use of electrocautery must be minimized if possible. iii)  Avoid the temptation to view the puncture endoscopically: the puncture must be undertaken under EUS guidance and with the aid of fluoroscopy to ensure the needle‐ knife or cystotome is not “jammed” into the soft tissue but is in line with the axis of the guidewire as it enters the bile duct. iv)  Use fcSEMS or LAMS for choledochoduodenostomies or hepaticogastrostomies instead of uncovered metals stents or plastic stents to minimize the chances of bile leakage and perforation. However, there is a small but real risk of causing cholecystitis by occluding the cystic duct with the fcSEMS, as well as a risk of stent migration.

­EUS-Guided Pancreatic Duct Access Similar techniques can be used to access the pancreatic duct by EUS‐guided puncture from the stomach. A guidewire can then be passed through into the duodenum, unless there is complete obstruction. There are few indications for this approach, which involve risk of leak and pancreatitis.

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­Conclusion Experienced endoscopists achieve cannulation using standard approaches in most cases. Rescue measures such as needle‐knife access and rendezvous techniques may be required when standard approaches fail. Because these techniques carry significant risks, it is clearly important to use them only when access is deemed to be essential. The most challenging procedures are in patients with altered surgical anatomy, where a combination of techniques or resources may be required to achieve therapeutic success. There is nothing more ideal than to be well prepared and have contingency plans when standard cannulation techniques fail. Adequate training and availability of requisite multidisciplinary resources is critical to ensure the success of advanced therapeutic interventions.

­References 1 Cote GA, Mullady DK, Azar RR, et al. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial. Dig Dis Sci 2012;57(12):3271–3278. 2 Glomsaker T, Hoff G, Soreide JA, et al. Patterns and predictive factors after endoscopic retrograde cholangiopancreatography. Br J Surg 2013;100(3):373–380. 3 Freeman ML, Nelson DB, Pheley AM, et al. Complications of endoscopic biliary sphincterotomy. N Eng J Med 1996;335(13):909–918. 4 Palm J, Saarela A, Mäkelä J. Safety of Erlangen precut papillotomy: an analysis of 1044 consecutive ERCP examinations in a single institution. J Clin Gastroenterol 2007;41:528–533. 5 Tarnasky PR, Palesch YY, Cunningham JT, et al. Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction. Gastroenterology 1998;115:1518–1524. 6 Binmoeller KF, Seifert H, Gerke H, et al. Papillary roof incision using the Erlangen‐type pre‐cut papillotome to achieve selective bile duct cannulation. Gastrointest Endosc 1996;44:689–695. 7 Catalano MF, Linder JD, Geenen JE. Endoscopic transpancreatic papillary septotomy for inaccessible obstructed bile ducts: comparison with standard pre‐cut papillotomy. Gastrointest Endosc 2004;60(4):557–561. 8 Katsinelos P, Gkagkalis S, Chatzimavroudis G, et al. Comparison of three types of precut technique to achieve common bile duct cannulation: a retrospective analysis of 274 cases. Dig Dis Sci 2012;57:3286–3292. 9 Misra SP, Dwivedi M. Intramural incision technique: a useful and safe procedure for obtaining ductal access during ERCP. Gastrointest Endosc 2008;67:629–633. 10 Farrell RJ, Khan MI, Noonan N, et al. Endoscopic papillectomy: a novel approach to difficult cannulation. Gut 1996;39:36–38. 11 Manes G, Di Giorgio P, Porro GB, et al. An analysis of the factors associated with the development of complications in patients undergoing precut sphincterotomy: a prospective, controlled, randomized, multicenter study. Am J Gastroenterol 2009;104(10):2412–2417.

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1 2 Singh P, Das A, Isenberg G et al. Does prophylactic pancreatic stent placement reduce the risk of post‐ERCP acute pancreatitis? A meta‐analysis of controlled trials. Gastrointest Endosc 2004;60:544–550. 13 Akaraviputh T, Lohsiriwat V, Swangsri J, et al. The learning curve for safety and success of precut sphincterotomy for therapeutic ERCP: a single endoscopist’s experience. Endoscopy 2008;40(6):513–516. 14 Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol 2007;13:2183–2186. 15 Harewood GC, Baron TH. An assessment of the learning curve for precut biliary sphincterotomy. Am J Gastroenterol 2002; 97:1708–1712. 16 Lin LF, Siauw CP, Ho KS, et al. ERCP in post‐Billroth II gastrectomy patients: emphasis on technique. Am J Gastroenterol 1999;94:144–148. 17 Lopes TL, Clements RH, Wilcox CM. Laparoscopy‐assisted ERCP: experience of a high‐ volume bariatric surgery center (with video). Gastrointest Endosc 2009;70:1254–1259. 18 Kim GH, Kang DH, Song CS, et al. Endoscopic removal or bile‐duct stones by using a rotatable papillotome and a large‐balloon dilator in patients with a Billroth II gastrectomy (with video). Gastrointest Endosc 2008;67(7):1134–1138. 19 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy 2007;39:958–961. 20 ASGE Committee on Training. ERCP core curriculum. Gastrointest Endosc 2006;63:361–376. 21 Dhir V, Bhandari S, Maydeo A, et al. Comparison or EUS‐guided rendezvous and precut papillotomy techniques for biliary access (with videos). Gastrointest Endosc 2012;75 (2):354–359. 22 Khashab MA, Valeshabad AK, Modayil R, et al. EUS‐guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc 2013;78:734–741. 23 Bang JY, Navaneethan U, Hasan M, et al. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc 2018;88: 9–17.

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10 Intraductal Therapies Zaheer Nabi and D. Nageshwar Reddy Asian Institute of Gastroenterology, Hyderabad, India

Key Points ●●

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Cholangiopancreatoscopy allows visualization of pancreato-biliary ductal systems for diagnostic as well as therapeutic applications. There are three different cholangiopancreatoscopy systems, that is, direct system that uses an ultra-slim endoscope and indirect systems where the cholangioscope is inserted through a therapeutic duodenoscope (mother-baby system or single-­ operator system). Direct cannulation using an ultra-slim scope may be difficult because of looping of the scope in the stomach and angulation of bile duct relative to the duodenum. The newly available digital cholangioscopes are preferred because of the ease of use and better image quality. The main diagnostic application of cholangioscopy includes evaluation of indeterminate biliary strictures and filling defects. The major therapeutic utility of cholangiopancreatoscopy is in the management of difficult biliary and pancreatic calculi using laser or electrohydraulic lithotripsy. Other intraductal therapies include radiofrequency ablation and photodynamic ­therapy in patients with cholangiocarcinoma. The majority of the diagnostic or therapeutic cholangiopancreatoscopy procedures require a prior sphincterotomy for ease of cannulation. Periprocedural antibiotics should be used to prevent infectious complications. Direct cholangioscopy should be performed under minimum insufflation using ­carbon dioxide to prevent air embolism

Imaging of the pancreato‐biliary tree has advanced significantly over the last few ­decades. With the availability of noninvasive techniques like magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS), ERCP has gradually evolved from a diagnostic tool to a therapeutic modality. However, the diagnosis remains a ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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c­ hallenge in some patients with pancreato‐biliary disorders even after extensive evaluation. This may be as a result of inherent characteristics of these diseases like biliary strictures, cholangiocarcinoma, or intraductal filling defects where conventional diagnostic modalities may not yield conclusive results. In addition, direct visualization of the interior of the pancreaticobiliary tree is not feasible with the traditional imaging modalities like MRCP and EUS. In recent years, the advances in techniques as well as technologies have enhanced the diagnostic as well as therapeutic capability of the endoscopists with respect to intraductal system (i.e. pancreato‐biliary ductal system). Now, the pancreatic and ­biliary ducts can be visualized from within with the advent of per‐oral cholangiopancreatoscopy (POCPS). Moreover, large biliary and pancreatic ductal (PD) calculi can be ­fragmented under direct vision. Other advances in intraductal therapies include photodynamic therapy (PDT), radiofrequency ablation (RFA), and brachytherapy for malignant biliary strictures. In this chapter we will discuss the advances in intraductal imaging and therapy for ­various pancreato‐biliary diseases (Table 10.1).

­Equipment and Techniques Per‐oral cholangioscopy (POCS) and pancreatoscopy (POPS) can be performed using three different systems: single operator, direct per‐oral cholangiopancreatoscopy (D‐POCPS); dual operator, indirect‐POCPS with mother‐baby system and single operator and indirect POCPS using SpyGlassTM system (Figure 10.1a–c, Table 10.2).

Table 10.1  Endoscopic-guided intraductal diagnostic and therapeutic procedures. Diagnostic

Therapeutic

Cholangiopancreatoscopy systems Direct cholangiopancreatoscopy ●● Indirect cholangiopancreatoscopy Dual operator (Mother baby system) Single operator (SpyGlass system)

Cholangioscopic intraductal lithotripsy Laser lithotripsy Electrohydraulic lithotripsy

Advanced Intraductal Imaging modalities Narrow band imaging ●● Confocal laser endomicroscopy ●● Optical coherence tomography

Selective guidewire cannulation

Indeterminate biliary strictures

Removal of migrated stents

Unexplained filling defects

Biliary ablation therapies Photodynamic therapy Radiofrequency ablation

Extent of malignant biliary strictures

Brachytherapy

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●●

Targeted biopsies under direct vision

10  Intraductal Therapies (a)

(b)

(c)

Figure 10.1  Different cholangioscopy systems. (a) Ultra-slim scope for direct per-oral cholangioscopy. (b) Dual operator, mother-baby cholangioscopy system. (c) Single-operator, indirect cholangioscopy system (SpyScope). Table 10.2  Per-oral cholangioscopy systems [1]. Distal diameter (mm)

Company

Model

Pentax

FCP‐9P

3.1 3.1

Accessory channel

Angulation

Field of view

1.2

90/90

90

1.2

160/130

90

1.2

240 (four way)

120

Mother-baby cholangioscopes

Olympus

CHF‐BP30

Boston Scientific

SpyGlass analog probe (reuse)

Company

Model

Angulation Up/down, Left/right

Shaft diameter

Accessory channel

Features

Olympus

GIF‐XP190N GIF‐XP180N GIF‐180N

210/90, 100/100 210/90, 100/100 210/120, ‐

5.8 5.5 4.9

2.2 2 2

NBI NBI NBI

Ultra-slim endoscopes for direct per-oral cholangioscopy

Pentax

PEF‐V

180/130, ‐

5.3

2

N/A

Fujinon

EG‐530N EG‐530NP EG 1690K

210/90, 100/100 210/120, ‐ 210/90, 120/120

5.9 4.9 5.1

2 2 2

FICE FICE iSCAN

Direct Per-Oral Cholangioscopy (D-POCS) D‐POCS involves the use of an ultra‐slim forward‐viewing endoscope (5 to 5.9 mm diameter, 2.0‐mm working channel) to cannulate the papilla directly. Various techniques can be used to cannulate the bile ducts using D‐POCS. With the freehand technique, the scope is passed into the second part of duodenum and the J maneuver performed. The tip of the scope is then deflected upward to enter the duct through a prior sphincterotomy. The major drawback with this technique is unstable position of the scope because of excess looping in the stomach and difficulty in cannulating the papilla as a result an acute bend in the second part of duodenum. To overcome this difficulty and improve cannulation rates, several ­techniques can be used. The use of an overtube helps in avoiding loop formation in the stomach. In the tandem technique, the ultra‐slim scope is railroaded over a guidewire ­previously placed in the duct during ERCP. Alternatively, a balloon catheter is advanced

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over a guidewire deep into the bile duct. The balloon is inflated, and traction is applied to help advance the endoscope into the duct (Figure 10.2a and b). Recent advances in the D‐POCPS include newer versions of cholangioscopes with ­double bending capability and novel accessories to facilitate biliary cannulation, including a hybrid balloon catheter anchoring device, modified access balloon catheter, and reusable guiding probe of Katz. The newer third‐generation prototype cholangioscopes (CHF‐Y0010, Olympus, Tokyo, Japan) have a slimmer distal tip (4.9 mm) with two ­bending sections. The proximal bending section can deflect up to 90° in a single plane (up and down) and the distal section can deflect up to 200° (vs 160° in second prototype version). It has two accessory channels (2.2 and 1 mm) with suction, insufflation, and irrigation capabilities [2]. The advantages of D‐POCPS are superior image quality, requirement of a single operator, and a 2‐mm working channel that allows many accessories for therapeutic interventions. However, the main difficulty is achieving direct cannulation with the ultra‐slim endoscope. Successful cannulation and maintenance of scope stability may require assistance of different accessories (as mentioned previously) adding to the duration and cost of the procedure. It may not be possible to obtain deep intrahepatic access and cross strictures due to the wider diameter of these scopes. In addition, bile duct perforation as a result of overinflation of the anchoring balloon and gas embolism are potential complications. Therefore, minimum carbon dioxide and saline irrigation should be used for insufflation instead of air. A wide sphincterotomy is also advisable to reduce intrabiliary pressure.

(a)

(b)

Figure 10.2  Balloon-assisted direct per-oral cholangioscopy using an ultra-slim scope. (a) Guidewire with balloon catheter inside the bile ducts (arrow pointing toward the inflated balloon). (b) Successful cannulation of bile duct.

10  Intraductal Therapies

Indirect POCPS: Mother and Baby POCPS Indirect POCPS can be performed with single‐operator or two‐operator systems. Table 10.2 summarizes the currently available POCPS methods. In the two‐operator procedure, also known as “mother and baby” cholangioscopy, a cholangioscope is passed through the accessory channel of a duodenoscope and then through the papilla for visualization of the biliary or pancreatic ductal structures. Two operators are required to handle the cholangioscope (baby scope) and the duodenoscope (motherscope) separately. The drawbacks of dual operator cholangioscopy are high cost, fragility of the instrument, single plane tip deflection, absence of separate irrigation channel, and requirement of two operators. Moreover, two processors along with light sources, video monitors, a fluoroscopy unit, and an irrigation pump are required. As a consequence, this system has fallen out of favor and is rarely used [3].

Indirect POCPS: SpyGlass Direct Visualization System The SpyGlassTM access and delivery system is a recent addition in the field of POCPS (Figure 10.3 a and b). The SpyScope access and delivery catheter has four lumens (one 1.2‐mm accessory channel and two independent irrigation channels) and measures 10 Fr in diameter. The delivery catheter has a handle with two knobs controlling the four‐way steering of the catheter. It can be attached to the handle of the duodenoscope for single‐operator use. The major advantage of this system is four‐way tip deflection, separate irrigation channels, and no requirement of two operators for the procedure. Improved maneuverability of the SpyGlassTM system allows for four quadrant biopsies. Recently, the SpyGlass DSTM direct visualization system (Microvasive Endoscopy, Boston Scientific, Natick, MA) has been introduced. The digital system (DS and DS II) is fully disposable and allows for better ­visualization of pancreatico‐biliary tree than the previous fiberoptic version (i.e. SpyGlass legacy). The third‐generation Spyglass DS II access and delivery catheter is the most recent

(a)

(b)

Figure 10.3  Single-operator cholangioscopy system. (a) SpyScope attached to the therapeutic duodenoscope just below the accessory channel. (b) Distal tip of SpyScope showing two irrigation channels and one accessory channel.

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version (2018) with improved resolution (2.5×) than the previous version (i.e. Spyglass DS from 2015). There are three accessory devices available including SpyBite biopsy forceps, SpyGlass retrieval basket (diameter 15 mm), and retrieval snare (diameter 9 mm) that can be used in taking targeted biopsies and removal of small stone fragments or removal of migrated stents.

­ pplication of Cholangioscopy and Pancreatoscopy A in Pancreato-Biliary Diseases Diagnostic Applications: Biliary The major diagnostic utility of POCPS is the endoscopic evaluation of indeterminate biliary strictures or filling defects. Modern cholangioscopes are equipped with narrow‐band imaging (NBI), which further enhances its diagnostic ability. POCPS can guide in delineating the longitudinal extent of biliary or pancreatic ductal malignancy prior to surgical resection and in assessing intraductal extension of an ampullary adenoma.

Indeterminate Biliary Strictures and Filling Defects Indeterminate biliary strictures are defined as biliary strictures that cannot be differentiated as benign or malignant with imaging and conventional sampling techniques like ERCP and brush cytology. The diagnostic yield of ERCP brush cytology is low (18–60%) possibly due to the desmoplastic reaction and low cellularity in these tumors. Cholangioscopy increases the diagnostic yield in patients with indeterminate strictures by allowing direct visualization and obtaining targeted biopsies. Cholangioscopic features associated with malignancy include dilated tortuous tumor vessels, intraductal nodules or masses, infiltrative or ulcerated strictures, and papillary or villous mucosal projections (Figure 10.4a–c). The features that suggest a benign lesion include smooth mucosa without neovascularization or homogenous granular mucosa without a mass. Overall, the accuracy of visual impression alone in diagnosing a malignant stricture ranges between 85% and 90% [4].

(a)

(b)

(c)

Figure 10.4  Cholangioscopy in a case of indeterminate filling defect. (a) Normal-appearing bile duct epithelium. (b) Nodular projection within the lumen of bile duct. (c) Targeted biopsy of the lesion under direct visualization.

10  Intraductal Therapies

Cholangioscopy‐directed biopsies have a good sensitivity (72%) and excellent specificity (99%) in the diagnosis of biliary malignancies [5].

Enhanced Intraductal Imaging Techniques Enhanced intraductal imaging techniques include cholangioscopy with NBI, chromocholangioscopy, autofluoroscence imaging (AFI), probe‐based confocal laser endomicroscopy (pCLE), and optical coherence tomography (OCT). NBI cholangioscopy improves the visualization of vessels and the surface topography over conventional white‐light cholangioscopy. Similarly, chromocholangioscopy using dyes like methylene blue improves the characterization of biliary mucosa. Homogenous uptake of the dye is a feature of benign epithelium, whereas heterogenous uptake or non‐ uptake are suggestive of dysplasia or malignancy. pCLE is another promising modality in cases with indeterminate biliary strictures. CLE provides 1000‐fold magnification of the epithelial and subepithelial tissue. Therefore, real‐ time microscopic examination can be performed. Intraductal CLE is performed using a specially designed probe (CholangioFlex probe, Maunakea Tech, Paris, France). This probe has an external diameter of 0.94 mm and can be passed through the accessory channel of a duodenoscope or cholangioscope. The probe has a radiopaque tip and can be positioned under cholangioscopic or fluoroscopic guidance. Characteristics suggestive of malignancy (Miami classification, 2012) include thick white bands (>20 μm), thick dark bands (>40 μm), or dark clumps or epithelial structures. However, the specificity is low (33%) as a result of false‐positives in cases with inflammatory changes in biliary tract. Subsequently, Paris classification proposed four descriptive criteria specific to benign inflammatory ­conditions, including vascular congestion, dark granular patterns with scales, increased interglandular space, and thickened reticular structure. Other enhanced intraductal imaging modalities like AFI and OCT have been shown to improve the diagnostic accuracy over ERCP in indeterminate strictures [3]. However, ­quality evidence is lacking, and these devices are not widely available.

D ­ iagnostic Applications: Pancreatic Pancreatoscopy can be used for visualization and histological evaluation of intraductal papillary mucinous neoplasm (IPMN), assessment of pancreatic ductal strictures or filling defects, and determining the extent of tumor prior to surgical resection. The devices and accessories used for pancreatoscopy are essentially the same as those for cholangioscopy. Differentiation of benign and malignant strictures can be difficult with ERCP alone. In these cases, visual impression of strictures during pancreatoscopy can be a valuable adjunct for distinguishing malignant and benign lesions. Pancreatoscopy findings in pancreatic cancer include coarse granular mucosa, erythema, friability, tumor vessels, papillary projections, protrusions, and infiltrative strictures (e.g. near occlusion of the lumen) with irregular margins [6]. In addition, pancreatoscopy can be used for taking biopsies under vision and obtaining pancreatic juice for cytopathological evaluation especially in cases with IPMN.

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The utility of pancreatoscopy in cases with suspected IPMN is twofold. First, it can help in differentiating IPMN from chronic pancreatitis with a dilated pancreatic duct. The features suggestive of benign IPMN on pancreatoscopy include granular mucosa, fish‐egg‐like protrusions without vascular images. Fish‐egg‐like protrusions with vascular images and villous protrusions and vegetative protrusions are suggestive of malignant IPMN. Second, the extent of IPMN can be determined which can help in identifying surgical margins.

I­ ntraductal Therapeutic Applications Cholangioscopy-Guided Therapies The main therapeutic indication of cholangioscopy is the management of difficult bile duct stones via intracorporeal lithotripsy. Other indications for POCPS include selective guidewire placement, diagnosis of unexplained hemobilia, assessing intraductal biliary ablation therapy, management of post‐liver transplant strictures, and extraction of migrated stents.

Intracorporeal Lithotripsy for Biliary Calculi Intracorporeal lithotripsy can be carried using cholangioscopy‐guided electrohydraulic lithotripsy (EHL) or laser lithotripsy. It may be especially useful in cases where the bile duct stones cannot be removed by conventional methods including ERCP with balloon dilatation and mechanical lithotripsy [7]. Typical examples include impacted stones, very large stones ( 25 mm), and stones above biliary strictures. Cholangioscopy allows direct visualization of stones and guides the positioning of an EHL probe or laser fiber onto the surface of stone. The success rate of cholangioscopy‐directed CBD stone removal by these methods ranges from 77% to 100% using EHL and 85–100% with laser lithotripsy [8]. Laser lithotripsy has been shown to outperform conventional ERCP techniques (like mechanical lithotripsy and large balloon dilatation) in achieving complete stone clearance during the same session with significantly less radiation exposure [9, 10]. An added advantage of cholangioscopic ­lithotripsy over ERCP is the ability to assess complete clearance of bile duct [11].

Technique of Electrohydraulic and Laser Lithotripsy EHL can be performed using a direct (ultra‐slim endoscope) or indirect (mother‐baby or Spyglass system) cholangioscopy systems. Alternatively, EHL can also be performed using a balloon catheter positioned under fluoroscopy guidance. However, the use of balloon catheter is not preferred because of potential of complications like duct trauma and perforation as a result of imprecisely targeted delivery of energy. Currently, single‐operator ­cholangioscopy system (Spyglass DS) is preferred because of improved image quality, four‐ way steerability of tip, and irrigation facility as compared to the first‐generation SpyGlass DS system (Figure 10.5a–d). In EHL, a single‐use bipolar lithotripsy probe (Nortech bilary probe:1.9 Fr, Olympus EHL probe: 2.4, 3 and 4.5 Fr) is passed through the accessory channel of a cholangioscope into the bile duct and positioned mm away from the distal end of a cholangioscope and

10  Intraductal Therapies (a)

(b)

(c)

(d)

Figure 10.5  Cholangioscopy-assisted lithotripsy in difficult biliary calculi. (a) Large calculus in bile duct targeted with electrohydraulic lithotripsy. (b) Complete fragmentation of calculus after electrohydraulic lithotripsy. (c) Impacted calculus in bile duct targeted under cholangioscopic vision. (d) Fragmentation of the calculus using laser lithotripsy.

1–2 mm from the target calculus. The EHL probe creates an electric high‐voltage spark between two electrodes on the tip of this probe, which generates hydraulic pressure waves in an aqueous medium leading to the fragmentation of calculi. Saline irrigation is required to create an aqueous medium, clear the debris, and improve visualization. For the same reason, a nasobiliary catheter is required for saline irrigation while using a mother‐baby cholangioscopy system. There are two commercially available electrohydraulic shock wave generators: Lithotron EL‐27 (Olympus, Tokyo, Japan) and Autolith Touch EHL units (Northgate Technologies Inc. [NTI], Elgin, IL). The latter has been approved by the Food and Drug Administration (FDA) for biliary stones. Power settings (low, medium, high), frequency (range 1–30/sec), and the number of shots delivered per foot pedal activation (range 1–60) can be adjusted in the Autolith system. As per the manufacturer recommendations low power and 3–5 pulses/ sec are sufficient in majority of the cases. The settings on generator can be modified on an individual case basis. Different settings may be required for impacted vs mobile stones and biliary vs pancreatic ductal stones [8].

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Laser Lithotripsy The holmium:yttrium aluminum garnet (YAG) laser and frequency‐doubled, double‐pulse neodymium:YAG (FREDDY) laser are the two commonly used lasers to fragment biliary stones. The holmium:YAG laser fibers are up to 4 m long and available in different diameters. The commonly used fibers for bile duct stones measure 550 μm or 1000 μm in diameter. The usual power settings on laser lithotripter units are 0.6 to 1.0 J at 6 to 10 Hz for total laser energy of 12 kJ. A green aiming beam is used to target the stone, and direct apposition is confirmed via cholangioscopic view. Laser bursts of less than 5 seconds are delivered under continuous saline solution irrigation. Care should be taken to avoid direct contact with tissue, and sufficient saline irrigation should be used to prevent adjacent thermal soft‐tissue effects. The distance between the laser fiber tip and stone should be 1 to 2 mm to achieve maximum stone fragmentation (Figure 10.5c and d). The recommended initial settings on FREDDY laser system are 120 mJ single pulse and 3 to 5 Hz repetition rate. The settings can be increased to 160 mJ and 10 Hz as per the results. The FREDDY laser causes minimal or no ductal injury and has been used through the guidewire port of a stone extraction balloon [8].

EHL vs Laser Lithotripsy Both the modalities of intracorporeal lithotripsy are highly effective in clearing difficult biliary stones. However, current evidence supports the use of laser lithotripsy over EHL. In a systematic review including 1969 patients, laser lithotripsy had a higher complete ductal clearance rate (95.1 %) than EHL (88.4 %). In addition, the stone fragmentation rate was higher for laser lithotripsy (92.5 %) than for EHL (75.5 %). The postprocedural complications were significantly higher after EHL (13.8% vs 9.6%, P = 0.04) [12]. Variables associated with reduced ductal clearance include surgically altered anatomy, strictures, significant ductal angulation, and impacted stones [1].

Intracorporeal Lithotripsy for Difficult Pancreatic Calculi Unlike cholangioscopy, the role of pancreatoscopy is less well defined in pancreatic calculi. Extracorporeal shock wave lithotripsy (ESWL) is the preferred first‐line therapy in chronic calcific pancreatitis. In difficult or refractory pancreatic ductal stones, POPS‐guided lithotripsy may be a useful adjunct to ESWL. In these cases, technical success with POPS‐lithotripsy can be achieved in 70–80% of cases [13, 14]. The presence of a tortuous pancreatic duct, stricture, multiple calculi, and stones located in body and tail limit the success of POPS. ERCP with sphincterotomy is usually performed prior to POPS to define the pancreatic ductal anatomy and delineate stones and strictures. Balloon dilatation of any stricture is also required to facilitate the passage of a pancreatoscope. Subsequently, POPS‐lithotripsy is performed using EHL or laser lithotripsy systems. Postprocedural pain and exacerbation of pancreatitis are commonly reported after POPS‐lithotripsy. Perioperative antibiotics are routinely administered to reduce chances of infection.

10  Intraductal Therapies

Photodynamic Therapy (PDT) for Malignant Biliary Strictures PDT is an ablative method that provides for local tumor control in patients with cholangiocarcinoma (CCA). In this procedure, a photosensitizer like Porfimer sodium (Photofrin, Pinnacle Biologics, Bannockburn, IL) is administered intravenously. The photosensitizer gets concentrated in the neoplastic biliary epithelium. ERCP is carried out after 48–72 hours to determine the extent of the tumor and the level of biliary obstruction. A targeted intraductal photoactivation is then performed endoscopically using a laser fiber and a diode laser system (InGaAIP, Laser Diode; Diomed Inc., Andover, MA). The tumor is irradiated for 10–12 min with laser light of wavelength 630 nm, fluence of 0.250 W/cm2, and a light dose of 180 J/cm2. Irradiation of the tumor with laser light leads to the activation of the photosensitizer resulting in the generation of free radical intermediates, which in turn activate cellular apoptosis, inflammatory, and antiangiogenic pathways [15]. The destruction of neoplastic tissue generates edema within the biliary tree. Therefore, a plastic or metal biliary stent is usually placed to prevent postprocedural cholangitis. Several studies and meta‐analyses have been published regarding the efficacy of PDT in addition to biliary stenting for the palliation of patients with unresectable CCA. In these studies, PDT has been found to improve the stent patency as well as the overall survival as compared to biliary stenting alone. The mean difference in overall survival ranges from 66 to 420 days in the published literature [15]. PDT has also been used in combination with chemotherapy to downstage unresectable tumors and prior to liver transplantation in selected candidates. In a retrospective study including 96 patients with unresectable CCA, the combination of PDT with chemotherapy was well tolerated and resulted in significantly higher median survival as compared to chemotherapy alone (20 months vs 10 months, P = 0.022) [16]. More evidence is needed regarding the efficacy of PDT for these indications (downstaging and combination with chemotherapy) and randomized trials are required before drawing conclusions. Major adverse events are uncommon with PDT. Phototoxicity is the most commonly observed complication and noticed in about 11% of patients [17]. Consequently, these patients are advised to avoid exposure to direct sunlight for 4–6 weeks. The other drawback of PDT is the high cost of photosensitizer agent (USD $24,512 per vial). In addition, the protocol for PDT needs to be standardized. For example, one session compared with two sessions of PDT, unilateral compared with bilateral PDT in type IV CCA, and the optimal interval between two sessions of PDT.

Radiofrequency Ablation (RFA) for Malignant Biliary Strictures RFA is an ablative method where heat energy is used to achieve contact coagulative necrosis of surrounding tissue (Figure 10.6a and b). Endobiliary RFA has been used to decrease tumor ingrowth in cases of CCA as well as malignant biliary strictures because of other etiologies (Figure 10.5). There are two endobiliary RFA probes available for commercial use: the ELRA Endobiliary RFA System (TaeWoong Medical, South Korea) and the Habib EndoHPB (Boston Scientific) [18]. The Habib catheter system is a bipolar probe with a diameter of 8 Fr and length of 1.8 m long. This catheter is compatible with standard duodenoscopes (3.2‐mm working channel) and passes over 0.035″ guidewires. There are two ring electrodes, each 8 mm apart, at the

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(b)

Figure 10.6  Radiofrequency ablation (RFA) in a case with cholangiocarcinoma. (a) Tight biliary stricture before RFA (b) Increase in the diameter of the stricture after RFA.

distal end of the catheter that provide local coagulative necrosis over a 2.5‐cm length. RFA procedure is performed using a standard duodenoscope and requires a sphincterotomy to allow the catheter to pass. After careful assessment of the stricture length, the ring electrodes are placed at the site of stricture under fluoroscopic guidance, and energy is delivered using an RFA generator (1500 RF generator; RITA Medical Systems Inc, Fremont, CA). The current setting of the RFA generator is kept at 400 kHz at 7–10 W for 2 minutes, with a rest period of 1 minute before moving the catheter. In cases with long strictures, RFA can be applied sequentially to cover the entire length of strictures. After RFA, a stent is usually placed to maintain the patency of biliary tract. RFA has been shown to improve the stent patency and survival in patients with unresectable malignant biliary strictures, although the evidence for the latter is less convincing as compared to PDT. In a randomized trial by Yang et al., RFA plus stenting was compared to stenting alone in patients with unresectable extrahepatic cholangiocarcinoma. The overall mean survival (13.2 ± 0.6 vs 8.3 ± 0.5 months; P 6 mm, alkaline phosphatase > upper limit normal [ULN], and ALT >3× ULN) that performed best in predicting a >75% risk of CDL [15]. Patients at medium risk. There are more options and decisions are more difficult when standard investigations suggest that the likelihood of duct stones falls into an intermediate (>5% but 3× ULN. ALT, alanine aminotransferase; CBD, common bile duct; CBDE, common bile duct exploration; CCX, cholecystectomy; CDL, choledocholithiasis; EUS, endoscopic ultrasound; IOC, intraoperative cholangiography; LFT, liver function test; MRCP, magnetic resonance cholangiopancreatography; ULN, upper limit normal.

CDL, ERCP expertise becomes most important. If ERCP expertise is limited, ancillary imaging may be helpful to confirm a diagnosis of CDL before ERCP. If ERCP expertise is available, it may be reasonable to proceed with CCX and use IOC to clarify whether CDL is present, and if so, treatment options would include laparoscopic CBDE, intraoperative ERCP, or postoperative ERCP.

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­Conclusions Treatment of CDL is the most common reason for ERCP in the peri‐CCX setting. ERCP may be indicated preoperatively for urgent indications such as cholangitis but also electively when there is a high likelihood for CDL. Intraoperative ERCP using a rendezvous technique is highly successful and safe but has logistical challenges. Patients with biliary symptoms shortly after CCX may benefit from ERCP to manage retained stones, bile leaks, or OBDI. Decisions regarding the timing of ERCP and their outcomes are dependent on available expertise and efficient collaborative efforts between endoscopy and surgical teams. Future developments in this arena may pertain to advances in surgical methods (e.g. minimally invasive robotic bile duct access) and therapeutic techniques.

R ­ eferences 1 Tenner S, Dubner H, Steinberg W. Predicting gallstone pancreatitis with laboratory parameters: a meta‐analysis. Am J Gastroenterol 1994;89(10):1863–1866. 2 Kuo VC, Tarnasky PR. Endoscopic management of acute biliary pancreatitis. Gastrointest Endosc Clin N Am 2013;23(4):749–768. 3 Tranter SE, Thompson MH. Spontaneous passage of bile duct stones: frequency of occurrence and relation to clinical presentation. Ann R Coll Surg Engl 2003;85(3):174–177. 4 Roston AD, Jacobson IM. Evaluation of the pattern of liver tests and yield of cholangiography in symptomatic choledocholithiasis: a prospective study. Gastrointest Endosc 1997;45(5):394–399. 5 Arguedas MR, Dupont AW, Wilcox CM. Where do ERCP, endoscopic ultrasound, magnetic resonance cholangiopancreatography, and intraoperative cholangiography fit in the management of acute biliary pancreatitis? A decision analysis model. Am J Gastroenterol 2001;96(10):2892–2899. 6 Tabone LE, Conlon M, Fernando E, et al. A practical cost‐effective management strategy for gallstone pancreatitis. Am J Surg 2013;206:472–477. 7 Ko CW, Lee SP. Epidemiology and natural history of common bile duct stones and prediction of disease. Gastrointest Endosc 2002;56(6 Suppl):S165–S169. 8 Dasari BV, Tan CJ, Gurusamy KS, et al. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev 2013;9:CD003327. 9 Collins C, Maguire D, Ireland A, et al. A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited. Ann Surg 2004;239(1):28–33. 10 Frossard JL, Hadengue A, Amouyal G, et al. Choledocholithiasis: a prospective study of spontaneous common bile duct stone migration. Gastrointest Endosc 2000;51(2):175–179. 11 Houdart R, Perniceni T, Darne B, et al. Predicting common bile duct lithiasis: determination and prospective validation of a model predicting low risk. Am J Surg 1995;170(1):38–43. 12 Hunt DR. Common bile duct stones in non‐dilated bile ducts? An ultrasound study. Australas Radiol 1996;40(3):221–222.

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1 3 Andrews S. Gallstone size related to incidence of post cholecystectomy retained common bile duct stones. Int J Surg 2013;11(4):319–321. 14 Maple JT, Ben‐Menachem T, Anderson MA, et al. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc 2010;71(1):1–9. 15 Chisholm PR, Patel AH, Law RJ, et al. Preoperative predictors of choledocholithiasis in patients presenting with acute calculous cholecystitis. Gastrointest Endosc 2019;89(5): 977–983 e2. 16 Sahai AV, Mauldin PD, Marsi V, et al. Bile duct stones and laparoscopic cholecystectomy: a decision analysis to assess the roles of intraoperative cholangiography, EUS, and ERCP. Gastrointest Endosc 1999;49(3 Pt 1):334–343. 17 Tse F, Barkun JS, Barkun AN. The elective evaluation of patients with suspected choledocholithiasis undergoing laparoscopic cholecystectomy. Gastrointest Endosc 2004;60(3):437–448. 18 Massarweh NN, Devlin A, Elrod JA, et al. Surgeon knowledge, behavior, and opinions regarding intraoperative cholangiography. J Am Coll Surg 2008;207(6):821–830. 19 Videhult P, Sandblom G, Rasmussen IC. How reliable is intraoperative cholangiography as a method for detecting common bile duct stones? A prospective population‐based study on 1171 patients. Surg Endosc 2009;23(2):304–312. 20 Bergamaschi R, Tuech JJ, Braconier L, et al. Selective endoscopic retrograde cholangiography prior to laparoscopic cholecystectomy for gallstones. Am J Surg 1999;178(1):46–49. 21 Horwood J, Akbar F, Davis K, et al. Prospective evaluation of a selective approach to cholangiography for suspected common bile duct stones. Ann R Coll Surg Engl 2010;92(3):206–210. 22 Coppola R, Riccioni ME, Ciletti S, et al. Selective use of endoscopic retrograde cholangiopancreatography to facilitate laparoscopic cholecystectomy without cholangiography. A review of 1139 consecutive cases. Surg Endosc 2001;15(10):1213–1216. 23 Ueno K, Ajiki T, Sawa H, et al. Role of intraoperative cholangiography in patients whose biliary tree was evaluated preoperatively by magnetic resonance cholangiopancreatography. World J Surg 2012;36(11):2661–2665. 24 Pierce RA, Jonnalagadda S, Spitler JA, et al. Incidence of residual choledocholithiasis detected by intraoperative cholangiography at the time of laparoscopic cholecystectomy in patients having undergone preoperative ERCP. Surg Endosc 2008;22(11):2365–2372. 25 Grubnik VV, Tkachenko AI, Ilyashenko VV, et al. Laparoscopic common bile duct exploration versus open surgery: comparative prospective randomized trial. Surg Endosc 2012;26(8):2165–2171. 26 Buxbaum J. Modern management of common bile duct stones. Gastrointest Endosc Clin N Am 2013;23(2):251–275. 27 Barkun AN, Barkun JS, Fried GM, et al. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. McGill Gallstone Treatment Group. Ann Surg 1994;220(1):32–39. 28 Clair DG, Carr‐Locke DL, Becker JM, et al. Routine cholangiography is not warranted during laparoscopic cholecystectomy. Arch Surg 1993;128(5):551–554; discussion 554–555. 29 O’Neill CJ, Gillies DM, Gani JS. Choledocholithiasis: overdiagnosed endoscopically and undertreated laparoscopically. ANZ J Surg 2008;78(6):487–491.

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3 0 Boerma D, Schwartz MP. Gallstone disease. Management of common bile‐duct stones and associated gallbladder stones: surgical aspects. Best Pract Res Clin Gastroenterol 2006;20(6):1103–1116. 31 Boerma D, Rauws EA, Keulemans YC, et al. Wait‐and‐see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile‐duct stones: a randomised trial. Lancet 2002;360(9335):761–765. 32 Helton WS, Ayloo S. Technical aspects of bile duct evaluation and exploration: an update. Surg Clin North Am 2019;99(2):259–282. 33 Brown LM, Rogers SJ, Cello JP, et al. Cost‐effective treatment of patients with symptomatic cholelithiasis and possible common bile duct stones. J Am Coll Surg 2011;212(6):1049–1060 e1‐7. 34 Petelin JB. Laparoscopic common bile duct exploration. Surg Endosc 2003;17(11):1705–1715. 35 Gilsdorf D, Henrichsen J, Liljestrand K, et al. Laparoscopic common bile duct exploration for choledocholithiasis: analysis of practice patterns of intermountain healthcare. J Am Coll Surg 2018;226(6):1160–1165. 36 Thompson MH, Tranter SE. All‐comers policy for laparoscopic exploration of the common bile duct. Br J Surg 2002;89(12):1608–1612. 37 Petelin JB. Surgical management of common bile duct stones. Gastrointest Endosc 2002;56(6 Suppl):S183–S189. 38 Taylor CJ, Kong J, Ghusn M, et al. Laparoscopic bile duct exploration: results of 160 consecutive cases with 2‐year follow up. ANZ J Surg 2007;77(6):440–445. 39 Fanelli RD, Gersin KS. Laparoscopic endobiliary stenting: a simplified approach to the management of occult common bile duct stones. J Gastrointest Surg 2001;5(1):74–80. 40 Bingener J, Schwesinger WH. Management of common bile duct stones in a rural area of the United States: results of a survey. Surg Endosc 2006;20(4):577–579. 41 Deslandres E, Gagner M, Pomp A, et al. Intraoperative endoscopic sphincterotomy for common bile duct stones during laparoscopic cholecystectomy. Gastrointest Endosc 1993;39(1):54–58. 42 Noel R, Enochsson L, Swahn F, et al. A 10‐year study of rendezvous intraoperative endoscopic retrograde cholangiography during cholecystectomy and the risk of post‐ERCP pancreatitis. Surg Endosc 2013;27(7):2498–2503. 43 Lella F, Bagnolo F, Rebuffat C, et al. Use of the laparoscopic‐endoscopic approach, the so‐called “rendezvous” technique, in cholecystocholedocholithiasis: a valid method in cases with patient‐related risk factors for post‐ERCP pancreatitis. Surg Endosc 2006;20(3):419–423. 44 Wang B, Guo Z, Liu Z, et al. Preoperative versus intraoperative endoscopic sphincterotomy in patients with gallbladder and suspected common bile duct stones: system review and meta‐analysis. Surg Endosc 2013;27(7):2454–2465. 45 Sarli L, Sabadini G, Pietra N, et al. Laparoscopic cholecystectomy and endoscopic sphincterotomy under a single anesthetic: a case report. Surg Laparosc Endosc 1995;5(1):68–71. 46 Richardson JF, Lee JG, Smith BR, et al. Laparoscopic transgastric endoscopy after Roux‐ en‐Y gastric bypass: case series and review of the literature. Am Surg 2012;78(10):1182–1186.

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4 7 Abbas AM, Strong AT, Diehl DL, et al. Multicenter evaluation of the clinical utility of laparoscopy‐assisted ERCP in patients with Roux‐en‐Y gastric bypass. Gastrointest Endosc 2018;87(4):1031–1039. 48 Kedia P, Tarnasky PR, Nieto J, et al. EUS‐directed transgastric ERCP (EDGE) versus laparoscopy‐assisted ERCP (LA‐ERCP) for roux‐en‐y gastric bypass (RYGB) anatomy: a multicenter early comparative experience of clinical outcomes. J Clin Gastroenterol 2019;53(4):304–308. 49 Sandha GS, Bourke MJ, Haber GB, et al. Endoscopic therapy for bile leak based on a new classification: results in 207 patients. Gastrointest Endosc 2004;60(4):567–574. 50 Pioche M, Ponchon T. Management of bile duct leaks. J Visc Surg 2013;150(3 Suppl):S33–S38. 51 Baillie J. Endoscopic approach to the patient with bile duct injury. Gastrointest Endosc Clin N Am 2013;23(2):461–472. 52 Mangieri CW, Hendren BP, Strode MA, et al. Bile duct injuries (BDI) in the advanced laparoscopic cholecystectomy era. Surg Endosc 2019;33(3):724–730. 53 Pekolj J, Alvarez FA, Palavecino M, et al. Intraoperative management and repair of bile duct injuries sustained during 10,123 laparoscopic cholecystectomies in a high‐volume referral center. J Am Coll Surg 2013;216(5):894–901. 54 Lau WY, Lai EC. Classification of iatrogenic bile duct injury. Hepatobiliary Pancreat Dis Int 2007;6(5):459–463. 55 Bergman JJGHM, van den Brink GR, Rauws EAJ, et al. Treatment of bile duct lesions after laparoscopic cholecystectomy. Gut 1996;38:141–147. 56 Csendes A, Navarrete C, Burdiles P, et al. Treatment of common bile duct injuries during laparoscopic cholecystecotmy: endoscopic and surgical management. World J Surg 2001;25:1346–1351. 57 Draganov P, Hoffman B, March W, et al. Long‐term outcome in patients with benign biliary strictures treated endoscopically with multiple stents. Gastrointest Endosc 2002;55:680–686. 58 Costamagna G, Tringali A, Mutignani M, et al. Endotherapy of postoperative biliary strictures with multiple stents: results after more than 10 years of follow‐up. Gastrointest Endosc 2010;72:551–557. 59 Garcia‐Cano J. Endoscopic management of benign biliary strictures. Curr Gastroenterol Rep 2013;15(8):336. 60 Tarnasky PR, Linder JD, Mejia A, et al. Bile duct obstruction after cholecystectomy caused by clips: undo what has been undone, then do what you normally do. Gastrointest Endosc 2009;69(4):e19–21.

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16 Difficult Bile Duct Stones Majid A. Almadi1 and Alan Barkun2 1 2

Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia Division of Gastroenterology, Montreal General Hospital, McGill University, Montreal, Quebec, Canada

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Removal of stones may be difficult because of their size (>12 mm diameter), their shape (piston type), their site (intrahepatic, cystic duct, or above strictures), or because of altered surgical anatomy. Management often requires prolonged or repeated procedures with different accessories and is associated with higher complication rates than standard stone removal. The approach should be tailored to the patient, the underlying biliary anatomy, the endoscopist’s experience, the clinical setting, and support available. A combination of techniques to enlarge the biliary orifice and to reduce the size of the stones may be needed to facilitate extraction. Management is best performed with a collaborative multidisciplinary approach using evidence-based methods and weighing the risks and benefits for a given patient.

I­ ntroduction ERCP and sphincterotomy is an established treatment for patients with common bile duct (CBD) stones. Although most stones can be extracted successfully using standard ­techniques [1,2], some are more challenging because of their size (Figure 16.1), shape, or position, and in patients with surgically altered anatomy [3, 4]. Several techniques may be required. These include enlarging the bile duct orifice or ­dilating a stricture, reducing the size of the stones by various form of lithotripsy, or by temporary stenting (Table 16.1).

ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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Figure 16.1  Large common bile duct stone demonstrated on occlusion cholangiogram.

Table 16.1  Possible approaches to treat large stones. Techniques that increase the biliary orifice Endoscopic sphincterotomy (ES) Endoscopic papillary balloon dilation (EPBD) Combination ES and EPBD Techniques that decrease stone size: lithotripsy Mechanical lithotripsy Extracorporeal (shock wave) lithotripsy Intracorporeal (intraductal) lithotripsy via cholangioscopy (Electrohydraulic, smart laser) Role of biliary stenting Biliary (plastic or metal) stents Stents with ursodeoxycholic acid Nasobiliary drain Back‐up methods Percutaneous transhepatic cholangiography (PTC) Surgery

­Techniques That Increase the Bile Duct Opening Endoscopic Papillary Balloon Dilation (EPBD) Although endoscopic sphincterotomy (ES) is the standard method for facilitating stone extraction, there is growing interest in using simple balloon dilation of the sphincter. This method may be as effective as ES and safer while theoretically preserving biliary

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sphincter function. It is widely applied in countries outside the United States for ­managing stones less than 1 cm in diameter. In the United States, it is currently reserved for patients with coagulopathy because of prior research showing a high risk of postprocedural pancreatitis. A meta‐analysis of 25 randomized controlled trials (RCTs) [5] showed that EPBD was equally efficacious compared with ES in stone removal at the first attempt with no difference in the need for mechanical lithotripsy, while there were lower odds of bleeding and short‐term cholecystitis compared to ES [5]. Compared to EPBD, ES is a risk factor for both stone recurrence and biliary sphincter dysfunction in studies with follow‐up periods of up to 7 years [6, 7]. Although CBD pressure, basal and peak sphincter pressures, as well as contraction frequency, have all been noted to be less after both EPBD and ES at 1 week and 1 year follow‐up compared to baseline, they are more preserved with EPBD [8].

Combination Endoscopic Sphincterotomy and Balloon Dilation This technique involves the performance of an ES to about half the length of the biliary sphincter. Following that, a dilating balloon (usually a controlled radial expansion [CRE] balloon) is inserted over a guidewire. The balloon diameter should be chosen according to the maximal diameter of the lower CBD based on the cholangiogram performed prior to the dilatation. Two‐thirds of the balloon should be inside the distal part of the CBD, while one‐third should be outside the papilla in the duodenal lumen. The balloon is inflated gradually using diluted contrast medium so the balloon is visible on fluoroscopy. The endoscopist should gradually increase the pressure in the balloon until the latter reaches the maximal lower CBD diameter or until the balloon waist disappears; if it does not, this finding might suggest the presence of a biliary stricture. A trial looking at the optimal duration (30 vs 60 seconds for each successive inflation pressure) of EPBD after ES in situations with large stones, with a maximal balloon diameter of 20 mm, found similar rates of successful clearance with no difference in complications [9]. The combination of ES and EPBD (balloon sphincteroplasty) has become popular for managing large stones (Figures 16.2–16.8). A four‐arm RCT [10] compared the use of ES vs EPBD vs EPBD followed by small ES vs a small ES followed by EPBD. There were no differences in rates of complete stone removal without the use of mechanical lithotripsy, in the rates of short‐ or long‐term complications, or in the number of sessions required. Park et al. [11] identified 25 studies and found ES with EPBD resulted in a higher rate of stone removal at the first endoscopic session compared to EPBD alone, while requiring less use of mechanical lithotripsy. However, ES with EPBD was associated with a higher risk of bleeding [11]. In the most recent American Society for Gastrointestinal Endoscopy (ASGE) guideline, a meta‐analysis of 9 RCTs compared ES with ES with EPBD; the authors reported higher success in clearing large stones by ES with EPBD with lower odds of requiring mechanical lithotripsy. There was no difference in cholangitis, pancreatitis, bleeding, or perforation, nor was there a difference in the clearance rate of stones at the initial ERCP [12]. The most recent European Society of Gastrointestinal Endoscopy (ESGE) and ASGE guidelines recommend limited sphincterotomy and EPBD as first‐line approach for removal of difficult CBD stones [12, 13].

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Figure 16.2  Partial sphincterotomy.

Figure 16.3  Insertion of the controlled radial expansion balloon.

Figure 16.4  Inflation of the controlled radial expansion balloon.

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Figure 16.5  Appearance of the papilla after partial sphincterotomy and endoscopic papillary balloon dilatation demonstrating some lower lying common bile duct stones.

Figure 16.6  Stones being extracted from the common bile duct.

Figure 16.7  Stones in the duodenum after extraction from the common bile duct.

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Figure 16.8  Insertion of a 10 Fr, 7‐cm biliary plastic stent into the common bile duct.

­Techniques to Decrease the Size of CBD Stones Stones greater than about 12 mm in diameter (the size of the scope on fluoroscopy) usually need to be fragmented to facilitate removal. There are several methods to achieve this endpoint: ●● ●● ●●

Mechanical lithotripsy Extracorporeal shock wave lithotripsy (ESWL) Intracorporeal lithotripsy, using cholangioscopy under 1) Electrohydraulic lithotripsy (EHL) or 2) Laser lithotripsy (LL) (Figure 16.9).

Mechanical lithotripsy uses large baskets that can be passed through therapeutic duodenoscopes. Capturing large stones can be challenging, especially those that fill the duct or are “piston‐shaped.” Engaging stones from below by slowly opening the basket may be more successful than the conventional method of trawling with an opened basket [14]. There are also “rescue” techniques, which involve taking the scope out, leaving the basket in place, and then passing a strong sleeve over the basket catheter (Figure 16.10a–d) ESWL uses equipment commonly employed for treating renal and pancreatic stones. Access to the equipment and the relevant expertise determine the local preference in using this technique to treat difficult biliary stones. Unless the stones are calcified, or targeted by ultrasound, it may be necessary to place a nasobiliary tube at ERCP to instill contrast, thus providing an image to focus the treatment. ERCP cholangioscopy has also been used to manage difficult stones (Figure 16.11a–c) as detailed in Chapter 10. Korrapati et al [15] suggested that single‐operator cholangioscopy is associated with a higher rate of technical success for stone‐related interventions when compared to dual‐operator “mother–daughter” cholangioscopy or with direct cholangioscopy using ultra‐slim endoscopes. At cholangioscopy, lithotripsy catheters are used with EHL generators or pulsed dye lasers (with or without safety features to minimize bile duct

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Figure 16.9  Fluoroscopic image of an inserted single operator cholangioscope into the intrahepatic ducts to facilitate an intervention.

injury, such as the smart lasers). The EHL generator is smaller and portable; there is also no need for special protective equipment nor electrical supply. The EHL probe generates a shock wave at its tip in a fluid medium, which leads to fragmentation of stones (Figure 16.12). The probe should be positioned 5 mm away from the tip of the cholangioscope and 1–2 mm from the stone surface prior to delivering the shock waves to achieve optimal fragmentation. Fluid immersion is critical because air causes interference and dissipates the shock wave energy. The LL approach has the advantage of a more accurate firing method when fragmenting stones, with smart lasers further mitigating the risk of bile duct injury. In a systematic review [16] comparing the three techniques in the management of CBD stones, a higher rate of stone fragmentation was found with LL (92.5%) compared to ESWL (89.3%) and EHL (75.5%), with better complete ductal clearance. The most recent ESGE guideline recommends the use of cholangioscopy‐assisted EHL or LL as effective and safe treatments for difficult CBD stones [13].

Role of Biliary Stents When stone extraction fails at ERCP, a biliary stent or stents should be placed to provide temporary biliary drainage. Some experts prefer double‐pigtail stents to reduce the risk of migration. Anecdotally it appears that stones are easier to remove after a few months of stenting. Previously, stents were thought to provide adequate long‐term treatment for stones that were difficult to remove in poor operative candidates. However, the risk of cholangitis is substantial, and every reasonable effort should be made to complete extraction.

Pharmacological Methods Ursodeoxycholic acid (UDCA), given orally, has been used in attempts to decrease the size of bile duct stones after placing stents, but studies have not confirmed efficacy. In a RCT, 41 patients with difficult stones [17], received 10 Fr straight plastic stents and were then

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(b)

(c)

(d)

Figure 16.10  (a) A cholangiogram demonstrating a large common bile duct stone. (b) A crushing basket is inserted into the common bile duct. (c) The stone is grasped with the basket. (d) Intracorporeal mechanical lithotripsy of the large common bile duct stone in performed.

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(b)

(c)

Figure 16.11  (a) The Spyglass single operator cholangioscope (courtesy of Boston Scientific, Natick, MA). (b) Fluoroscopic insertion of a single operator cholangioscope for selective cannulation of intrahepatic ducts. (c) Endoscopic visualization of stone fragments after electrohydraulic lithotripsy with a single operator cholangioscope.

randomized to receive UDCA or placebo for 6 months. There was no significant difference in stone size reduction or subsequent clearance between the two groups. In another RCT by Lee et al. [18], elderly patients with difficult stones were randomized to multiple 7 Fr pigtail stents alone or to stents with UDCA and terpene. Stone size decreased significantly during the follow up period of 6 months in both arms, but there was no significant ­difference in stone removal rates. A randomized trial using UDCA for the prevention of

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Figure 16.12  Electrohydraulic lithotripsy probe in proximity to the stone and on activation resulting in fragmentation of stones.

recurrent duct stones after the clearance of the biliary system found no measurable benefits, but the study was small and the follow‐up short [19]. Methyl tert‐butyl ether, infused through a nasobiliary drain, was used years ago to manage difficult stones in a few centers but carried significant risks. This technique has since been largely abandoned.

­Stones in Difficult Positions Mirizzi Syndrome A stone in the cystic duct or neck of the gallbladder (Figure 16.13) can cause obstruction of the common hepatic duct either as a result of the stone itself or as a result of associated inflammation [20]. This condition can be difficult to recognize during ERCP and often impossible to treat definitively. Stent placement can provide drainage and facilitates subsequent surgery. Cholangioscopy‐guided intervention has been successful in a few cases when cystic duct access is possible.

Intrahepatic Stones ERCP has a limited application in patients with intrahepatic stones, especially when there are multiple strictures. In the setting of oriental cholangiohepatitis, surgery (e.g. segmental resection of the liver or hemi‐hepatectomy) is usually the best definitive treatment [21]. At endoscopy, an attempt to reposition the intrahepatic stones into the main hepatic duct or the larger lumen downstream biliary system can be made using a piston maneuver where the suction effect of an inflated extraction balloon below or above the stones may help dislodge and bring them into the main duct, where removal can be more readily achieved. Cholangioscopy can be used for direct cannulation of the affected intrahepatic ducts with

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Figure 16.13  Mirizzi syndrome: the thin arrow shows stones in cystic duct, and the thick arrow shows stones in infundibulum of the gallbladder and cystic duct obstructing the common bile duct.

visualization of the stone and subsequent lithotripsy. Cholangioscopy can also be used to position guidewires when other manipulation efforts fail; this facilitates subsequent interventions.

Surgically Altered Anatomy The two most commonly encountered surgically altered anatomies are Billroth II and Roux‐en‐Y surgical reconstructions, with the former becoming less of an issue because of the decreased use of such surgery in the management of peptic ulcer disease and the latter becoming more common owing to an increase in bariatric surgery. In managing these patients, reaching the papilla, cannulating the biliary system, and delivering appropriate interventions can be a challenge. The approach taken will be dictated by the type of resection, type of reconstruction, length of the pancreato‐biliary limb, and type of anastomosis. Some surgeries do not or have minimal effect on an ERCP procedure as access to the papilla and the biliary system is maintained (e.g. esophagectomy with a gastric pull‐up, sleeve gastrectomy, laparoscopic adjustable gastric band placement, and Billroth I) [22]. Other surgeries require either a different set of equipment, including scopes, and might require laparoscopic assistance depending on the length of the length of the surgically

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altered limb (e.g. pylorus‐preserving pancreaticoduodenectomy [Whipple procedure], Roux‐en‐Y hepaticojejunostomy, and Roux‐en‐Y gastric bypass) [22]. In cases when the anastomotic limb is especially long, a pediatric colonoscope, enteroscope, or double‐balloon enteroscopes (with a shorter length of 152 cm) might be needed with or without placement of a cap at the distal scope tip to facilitate cannulation. In such cases, the access to the biliary system will be in the 5 o’clock direction on the ampulla as opposed to the usual 11 o’clock position. As such, cannulating using a regular sphincterotome would be difficult, and special sphincterotomes for these cases are commercially available. With Billroth II anatomy, most experts use the standard side‐viewing duodenoscope (with an elevator) to approach the papilla from below, place a temporary biliary stent, and then perform a sphincterotomy with a needle‐knife over the stent. Any subsequent therapeutics can be carried out, keeping in mind the inverted anatomy and position of the scope in relation to the long axis and direction of the common bile duct.

­Additional Interventions and Collaboration When endoscopic therapy fails, alternative methods must be considered. Surgery was avoided in high‐risk patients previously but is now remarkably safe and should take precedence, especially when the gallbladder is still in situ. Similarly, the percutaneous transhepatic approach is a good option in expert hands. A multidisciplinary approach involving experienced endoscopists, interventional radiologists, and surgeons should be adopted to optimize outcomes.

­Existing Guidelines and Consensus Recommendations Guidelines on the topic of difficult CBD stones have been published by the ASGE [12, 23–25], Society of American Gastrointestinal and Endoscopic Surgeons [26], American Gastroenterological Association [27], American College of Gastroenterology [28], British Society of Gastroenterology [29], and the European Society of Gastrointestinal Endoscopy [13].

R ­ eferences 1 Classen M, Hagenmuller F. Treatment of stones in the bile duct via duodenoscopy. Endoscopy 1989;21 Suppl 1:375–377. 2 Peng C, Nietert PJ, Cotton PB, et al. Predicting native papilla biliary cannulation success using a multinational endoscopic retrograde cholangiopancreatography (ERCP) Quality Network. BMC Gastroenterol 2013;13:147. 3 Almadi MA, Eltayeb M, Thaniah S, et al. Predictors of failure of endoscopic retrograde cholangiography in clearing bile duct stone on the initial procedure. Saudi J Gastroenterol 2019;25:132–138.

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4 Almadi MA, Barkun JS, Barkun AN. Management of suspected stones in the common bile duct. CMAJ 2012;184:884–892. 5 Tringali A, Rota M, Rossi M, et al. A cumulative meta‐analysis of endoscopic papillary balloon dilation versus endoscopic sphincterotomy for removal of common bile duct stones. Endoscopy 2019;51:548–559. 6 Yasuda I, Fujita N, Maguchi H, et al. Long‐term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Gastrointest Endosc 2010;72:1185–1191. 7 Tanaka S, Sawayama T, Yoshioka T. Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: long‐term outcomes in a prospective randomized controlled trial. Gastrointest Endosc 2004;59:614–618. 8 Yasuda I, Tomita E, Enya M, et al. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function? Gut 2001;49:686–691. 9 Paspatis GA, Konstantinidis K, Tribonias G, et al. Sixty‐ versus thirty‐seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: a randomized controlled trial. Dig Liver Dis 2013;45:301–304. 10 Chu X, Zhang H, Qu R, et al. Small endoscopic sphincterotomy combined with endoscopic papillary large‐balloon dilation in the treatment of patients with large bile duct stones. Eur Surg Acta Chirurgica Austriaca 2017;49:9–16. 11 Park CH, Jung JH, Nam E, et al. Comparative efficacy of various endoscopic techniques for the treatment of common bile duct stones: a network meta‐analysis. Gastrointest Endosc 2018;87:43–57.e10. 12 Buxbaum JL, Abbas Fehmi SM, et al. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc 2019;89:1075–1105. 13 Manes G, Paspatis G, Aabakken L, et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2019;51:472–491. 14 Shi D, Yu CG. Comparison of two capture methods for endoscopic removal of large common bile duct stones. J Laparoendosc Adv Surg Tech 2014;24:457–461. 15 Korrapati P, Ciolino J, Wani S, et al. The efficacy of peroral cholangioscopy for difficult bile duct stones and indeterminate strictures: a systematic review and meta‐analysis. Endosc Int Open 2016;4:E263–E275. 16 Veld JV, Van Huijgevoort NCM, Boermeester MA, et al. A systematic review of advanced endoscopy‐assisted lithotripsy for retained biliary tract stones: laser, electrohydraulic or extracorporeal shock wave. Endoscopy 2018;50:896–909. 17 Katsinelos P, Kountouras J, Paroutoglou G, et al. Combination of endoprostheses and oral ursodeoxycholic acid or placebo in the treatment of difficult to extract common bile duct stones. Dig Liver Dis 2008;40:453–459. 18 Lee TH, Han JH, Kim HJ, et al. Is the addition of choleretic agents in multiple double‐pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study. Gastrointest Endosc 2011;74:96–102. 19 Yamamoto R, Tazuma S, Kanno K, et al. Ursodeoxycholic acid after bile duct stone removal and risk factors for recurrence: a randomized trial. J Hepatobiliary Pancreat Sci 2016;23:132–136.

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20 Johnson LW, Sehon JK, Lee WC, et al. Mirizzi’s syndrome: experience from a multi‐institutional review. Am Surg 2001;67:11–14. 21 Cheung MT, Kwok PC. Liver resection for intrahepatic stones. Arch Surg 2005;140:993–997. 22 Committee AT, Enestvedt BK, Kothari S, et al. Devices and techniques for ERCP in the surgically altered GI tract. Gastrointest Endosc 2016;83:1061–1075. 23 Committee ASoP, Maple JT, Ikenberry SO, et al. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc 2011;74:731–744. 24 Committee ASoP, Maple JT, Ben‐Menachem T, et al. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc 2010;71:1–9. 25 Committee ASoP, Chathadi KV, Chandrasekhara V, et al. The role of ERCP in benign diseases of the biliary tract. Gastrointest Endosc 2015;81:795–803. 26 Overby DW, Apelgren KN, Richardson W, et al. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc 2010;24:2368–2386. 27 Crockett SD, Wani S, Gardner TB, et al. American Gastroenterological Association Institute clinical guideline on initial management of acute pancreatitis. Gastroenterology 2018;154:1096–1101. 28 Tenner S, Baillie J, DeWitt J, et al. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol 2013;108:1400–1415; 1416. 29 Williams E, Beckingham I, El Sayed G, et al. Updated guideline on the management of common bile duct stones (CBDS). Gut 2017;66:765–782.

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17 Patients with Obscure Biliary Pain; Sphincter of Oddi Dysfunction Peter B. Cotton Digestive Disease Center, Medical University of South Carolina, Charleston, SC, USA

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Modern imaging methods (computed tomography [CT], magnetic resonance ­cholangiopancreatography [MRCP], and endoscopic ultrasound [EUS]) have replaced diagnostic ERCP for investigation of suspected biliary and pancreatic pain. The use of ERCP for managing sphincter of Oddi dysfunction is controversial. The incidence of post‐ERCP pancreatitis is high in this context. Sphincter manometry is now rarely practiced. More stringent research is urgently needed.

Before the days of sophisticated imaging techniques, ERCP was frequently and effectively used to investigate patients with biliary and pancreatic type pain to diagnose and exclude common diseases such as bile duct stones, tumors, and chronic pancreatitis. The situation is now entirely different. Careful clinical enquiry and less‐invasive investigations (computed tomography [CT], magnetic resonance cholangiopancreatography [MRCP], and endoscopic ultrasound [EUS]) have replaced ERCP in this context. The only potential remaining indication for ERCP in patients with negative imaging studies is suspected sphincter of Oddi dysfunction (SOD). It may be considered in patients with pain after cholecystectomy and in some with idiopathic recurrent pancreatitis (discussed in Chapter 20). The simple and intuitive concept is that inappropriate sphincter activity can cause pain by increasing the pressure in the biliary and pancreatic ducts and that relieving the pressure by sphincter ablation is the logical treatment. However, the role of ERCP management is controversial. Outcomes are not predicable and the risks are substantial, with postprocedural pancreatitis rates of 15–30%.

ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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ERCP management with sphincter manometry was popularized more than 30 years ago by the Milwaukee group. They introduced a classification system [1]. The definitions, as updated later [2], were: ●●

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Type I: patients with pain, abnormal liver tests on two occasions, and a dilated bile duct (>10 mm). Type II: abnormal liver tests or a dilated duct, but not both. Type III: no abnormal findings.

These distinctions appeared logical, and they provided a framework for discussing management, but their relevance to practice is questioned [3]. It is also pertinent to note that application of these criteria is not clear‐cut. The definition of a dilated bile duct is anecdotal. Contrary to popular opinion, careful research shows that the duct does not get (significantly) bigger simply because of cholecystectomy. Some experts require the liver tests (transaminases) to peak with attacks of pain and normalize afterward, but these data are often not available, and there is currently no evidence that the criterion is helpful.

­SOD Type I Multiple studies have shown that Type I patients (with clear objective evidence for biliary obstruction) have structural problems (e.g. sphincter stenosis or small stones), which can be well assessed by EUS. They are treated effectively by biliary sphincterotomy. SOD type II is the most controversial group and is best discussed after describing new insights gained when investigating SOD III.

­SOD Type III These patients have biliary‐type pains but no objective evidence for biliary obstruction (i.e. a normal‐sized bile duct and normal liver enzymes). Thousands of such patients have been being treated by biliary sphincterotomy with or without sphincter manometry. Some centers reported high success rates, but others were less impressive. Everyone agreed that the procedure was risky, causing pancreatitis in 15–30% of cases and a few perforations. In addition, patients with persistent pains were subjected to multiple repeat ERCPs and even surgical procedures. Concern about the situation led to the Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD) study reported in 2014 [4]. The goal of the study was to identify the characteristics of the patients who benefited from sphincterotomy (and the role of manometry) to better inform future practice. In it, 214 patients with impressive post‐cholecystectomy pain underwent ERCP with biliary and pancreatic manometry. They were then randomized to sphincterotomy or no treatment, irrespective of the manometry results. All received a temporary small pancreatic stent to reduce the risk of pancreatitis. The patients were carefully followed for 1 year. They, their caregivers, and the outcome assessors were all blinded to the intervention. At 1 year, the success rates, as measured by reduction in pain (without re‐intervention) were no different

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(23% for sphincterotomy, 37% for sham). At 5 years, the sham‐treated subjects were doing statistically better! Manometry results and clinical characteristics did not correlate with outcomes. Post‐ERCP pancreatitis occurred in about 15% of cases; there were two perforations and no deaths. These results came as surprise to many experts in the field, who could claim many hundreds of grateful patients, but the conclusion was clear. ERCP sphincterotomy is no longer indicated in this context. Why so many sham‐treated patients did so well shows the power of the placebo effect, which, despite an extensive literature, has not been recognized sufficiently in everyday practice. I have expanded on this elsewhere [5]. Strictly speaking, type III patients have normal liver enzymes. However, because elevated tests (especially transaminases) are found commonly in the asymptomatic US population, we did include some in the EPISOD study. Their outcomes were no different, raising questions about the use of ERCP, manometry, and sphincterotomy in type II patients.

­SOD Type II The results of the EPISOD study have raised questions about ERCP management of patients with type II SOD (i.e. a dilated bile duct or elevated liver enzymes). Belief in this diagnosis and justification for ERCP treatment is based on much anecdotal clinical experience, some cohort studies, and more firmly, on two randomized sham‐controlled trials [6]. The numbers in those studies were small and the placebo responses impressive, but the patients with elevated biliary pressures who were treated by sphincterotomy did statistically better than the other groups. These reports resulted in manometry‐directed sphincterotomy (of the pancreatic as well as the biliary sphincter without further evidence) becoming standard practice in many referral centers and was blessed by a National Institutes of Health (NIH) ERCP State of the Science conference in 2002 [7]. However, manometry is now rarely performed in practice. It is technically fiddly and was believed (mistakenly) to increase the risk of postprocedural pancreatitis above that of ERCP alone. Many clinicians now offer a “trial of sphincterotomy” to these patients. It seems likely that some patients do benefit from such treatment over and above the strong placebo effect, but many do not. More stringent research is needed to clarify the best indications and thereby reduce the burden of unsuccessful interventions and the substantial inherent risks. In the meantime it behooves clinicians to enter this minefield with great care, to reassure their patients, to try medical treatments, and to consider ERCP and sphincterotomy only when severe symptoms persist and in patients fully informed of the risks.

­Alternative Treatments for SOD Botox injection into the sphincter at ERCP has been proposed as an alternative to sphincterotomy. The technique is straightforward, and some anecdotal results were impressive [8], but there has been no definitive study. Surgical sphincteroplasty has also been used, mainly in patients with recurrent symptoms after ERCP sphincterotomy. Published results are difficult to interpret.

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­Goodbye, Biliary Types I, II, and III Because patients with impressive objective biliary findings (type I) have structural problems, and those with none (type III) do not have a sphincter problem (they do not respond to ablation), the terms should be abandoned. We are left with “suspected sphincter of Oddi dysfunction,” awaiting further research [9].

­Medical Treatments While we abandon the term SOD III, we must not abandon the patients, who often have disabling pain. They may benefit from behavioral therapies and antispasmodic medications. A small trial of a neuromodulator (duloxetine) showed promise [10]. Further research is urgently needed.

SOD in Patients Who Still Have a Gallbladder? Previous studies proposed performing biliary sphincterotomy in patients with pain and normal gallbladder findings. This practice is not evidence‐based and not recommended [9].

Pancreatic SOD A classification for pancreatic SOD has been described [11]. However, there is no good evidence that SOD can cause attacks of pancreatic pain, and ERCP and manometry and pancreatic sphincterotomy are not indicated [10]. The role of SOD in idiopathic recurrent pancreatitis is also controversial and currently subject to research.

­Conclusion ERCP now has little role in the management of patients with biliary and pancreatic pain in the absence of impressive laboratory or imaging findings. There are few predictable benefits and substantial risks. Further, stringent research is essential to clarify the predictors of benefit over and above the impressive placebo response. Patients and doctors should use great caution when approaching this minefield.

­References 1 Hogan WJ, Geenen JE. Biliary dyskinesia. Endoscopy 1988;20 (Suppl 1):179–183. 2 Sherman S, Lehman GA. Sphincter of Oddi dysfunction: diagnosis and treatment. J Pancreas 2001;2:382–400. 3 Freeman ML, Gill M, Overby C, et al. Predictors of outcomes after biliary and pancreatic sphincterotomy for sphincter of Oddi dysfunction. J Clin Gastroenterol 2007;41(1):94–102.

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4 Cotton PB, Durkalski V, Romagnuolo J, et al. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain‐related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA 2014;311(20):2101–2109. 5 Cotton PB. Why did the sham‐treated EPISOD study patients do so well? Important lessons for research and practice. Gastrointest Endosc 2019;89:1054–1055. doi: 10.1016/j. gie.2018.11.006. 6 Petersen BT. An evidence‐based review of sphincter of Oddi dysfunction: part 1, presentations with “objective” biliary findings (types I and II). Gastrointest Endosc 2004;59:525–534. 7 Cohen S, Bacon BR, Berlin JA, et al. National Institutes of Health State‐of‐the‐Science Conference statement: ERCP for diagnosis and therapy, January 14–16, 2002. Gastrointest Endosc 2002;56:803–809. 8 Murray W, Kong S. Botulinum toxin may predict the outcome of endoscopic sphincterotomy in episodic functional post‐cholecystectomy biliary pain. Scand J Gastroenterol 2010 May;45(5):623–627. 9 Cotton PB, Elta GH, Carter CR, et al. Rome IV. Gallbladder and Sphincter of Oddi Disorders. Gastroenterology 2016;150:1420–1429. 10 Pauls Q, Durkalski‐Mauldin V, Brawman‐Mintzer O, et al. Duloxetine for the treatment of patients with suspected sphincter of oddi dysfunction: a pilot study. Dig Dis Sci 2016;61(9):2704–2709. 11 Petersen BT. Sphincter of Oddi dysfunction, part 2: evidence‐based review of the presentations, with “objective” pancreatic findings (types I and II) and of presumptive type III. Gastrointest Endosc 2004;59:670–687.

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18 Benign Biliary Strictures John T. Cunningham Section of Gastroenterology and Hepatology, University of Arizona School of Medicine, Tucson, AZ, USA

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The common causes of benign biliary strictures are postoperative (post‐cholecystectomy and liver transplant), chronic pancreatitis, and primary sclerosing cholangitis (PSC). IgG4‐associated sclerosing cholangitis (IgG4‐SC) is a less common etiology. Magnetic resonance cholangiopancreatography (MRCP) now allows accurate early diagnoses without risk and the opportunity to consider the best approaches. Direct cholangioscopy with biopsy may be needed to differentiate PSC from IgG4‐SC. A multidisciplinary approach is necessary to be able to advise patients optimally. ERCP treatment with stenting (e.g. multiple plastic stents or fully covered self‐ expandable metal stents) is usually effective in postoperative strictures, less so in patients with chronic calcific pancreatitis and unproven in PSC. The most common recommendation for ERCP management in PSC is stricture balloon dilation rather than short term stenting.

I­ ntroduction The first biliary plastic stents were modified urological stents adapted by Soehendra for relief of malignant obstructive jaundice [1]. Realization that small stents tend to block quickly led to the development of instruments and devices to allow placement of larger stents with longer patency [2]. The techniques rapidly became popular because they could be carried out with less morbidity than surgical bypass [3]. The situation in patients with benign biliary strictures is different because of the potential for extended survival. The challenge is to maintain duct patency long term to prevent cholangitis and resulting cirrhosis [4]. This can be achieved in most but not all cases endoscopically with multiple plastic stents or self‐expanding metals stents (SEMS). Surgical bypass is an option that should be considered in some cases [5]. ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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­Chronic Pancreatitis (CP) Temporary cholestasis resulting from biliary obstruction in acute pancreatitis can respond favorably to placement of a single 10 F plastic stent pending resolution of the acute process. Persistent and severe biliary strictures occur in up to 11% of patients with secondary to advanced CP [4], and the response to treatment with repeated single plastic stents is poor [6]. Multiple plastic 10 F stents have been associated with a higher long‐term success, but the presence of calcific pancreatitis is associated with more failures [7–8]. The total ­duration of treatment was at least 12 months [8]. There was one episode of inward stent migration managed by ERCP. Overall success at a mean of 3.6 years was 92%, including 5 of the 6 patients with pancreatic calcifications. Other series with multiple stents claimed success in less than half of the patients with CP [7]. Interestingly, there were no episodes of clinical cholangitis during the phase of the multiple stenting. This finding is supported by another center that reported only one episode in 22 patients with stents in place for more than 6 months [9]. SEMS were introduced for use in malignant biliary obstruction but have gradually been employed also in benign biliary strictures resulting from CP [10–11]. One study showed initial enthusiasm in 20 patients with no early complications and mean 3.3 years follow‐up, with only two stent occlusions secondary to intimal hyperplasia [11]. Two studies with longer follow‐up (5 or more years) revealed significant complications, including symptomatic occlusions in 63% due either to stone formation and intimal hyperplasia [10], one stent‐related death due to cholangitis, and two further occlusions in the 5 patients surviving 5 years [12]. The problem that uncovered or partially covered SEMS may not be readily removable [13] has led to development of covered SEMS, including stents with only a small proximal uncovered rim. Covered stents are less likely to become occluded by intimal hyperplasia and are potentially removable. The first generation were partially covered with a variable rim of bare metal on the proximal and distal ends. A pilot study with the partially covered 30 F Wallstents (Boston Scientific, Natick, MA) in 14 patients with CP reported spontaneous migration in two patients and intimal overgrowth in five patients which began at 18 months after insertion with no plan for elective removal [14]. Multiple reports of problems with occlusion and removal with fully or partially uncovered SEMS has led to the development of fully covered SEMS (fcSEMS). An interim report on the 10‐mm fully ­covered Viabil (ConMed, Utica NY) stent in 19 patients with CP demonstrated stricture resolution in 65%, with stent migration in 1 patient whose stricture had resolved [15]. To have an appreciation for what multiple plastic stents accomplish relative to metal stents the circumference achieved by five 10 F stents is 31 mm, which is equivalent to a single 10‐mm diameter metal stent. An 8‐mm diameter metal stent has a circumference diameter of 25.3 mm, and four 10 F stents is 27 mm. A prospective randomized trial of multiple plastic ­compared with single metal fcSEMS in 35 patients, (17 plastic vs 18 fcSEMS) showed ­stricture resolution was not statistically different between the two groups, but stricture ­resolution occurred earlier with metal stents [16]. With the significant failure rate of endoscopic treatment in this context, even with multiple stents and SEMS, operative bypass remains a viable alternative, especially if they are also candidates for surgery on the pancreas itself at the same operation (e.g. pancreaticojejunostomy).

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The Amsterdam group reported on 42 patients who responded initially to stent placement but were assessed for surgery due to the need for repeated stenting or complications of pancreatitis. Twenty‐six patients were poor operative candidates or refused surgery and continued with plastic stents or SEMS. Sixteen patients underwent some form of biliary diversion with significant postoperative morbidity in 6 (38%) but with jaundice resolution in 15 and no long‐term complications [17]. Late complications occurred in 64% of the patients who were treated with stents alone. However, this was not a prospective study, and current stenting protocols could have produced a different outcome.

P ­ ostoperative Strictures Benign strictures resulting from cholecystectomy or orthotopic liver transplant (OLTX) are different from those as a result of CP. They are typically higher in the duct and may extend into the bifurcation in the case of hepatic artery occlusion in patients post‐OLTX or at the surgical anastomosis (Figure  18.1). The results with endoscopic stenting for strictures below the bifurcation are similar for post‐transplant and post‐cholecystectomy strictures and are clearly better with multiple as opposed to single plastic stents (Figure 18.2) [18–19]. Long‐term success rates of 80–90% have been reported with multiple plastic stents [19–20]. The concerns for problems with the proximal uncovered portion of the stent resulted in the development and use of fcSEMS [15–16, 21–24]. The first two studies used either the Nit‐S ComVi (Taewoong Medical Seoul, Korea) in 16 patients [22] or the Wallflex (Boston Scientific, Natick, MA) in 11 patients, all of whom had failed prior therapy with dilation or plastic stent placement. Outward stent migration occurred in 11 of 27 (41%), but the stricture had resolved in most of those cases. Four of the patients ultimately underwent surgical bypass for failure or stricture recurrence. Another study in benign biliary strictures involved 62 patients treated

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Figure 18.1  (a) Patient 1 month after liver transplant with high bilirubin, ERCP with tight anastomotic stricture (arrow). (b) Stricture dilated with a 10 F dilation and single 10 Fr biliary stent. (c) First follow‐up ERCP after stent removal with persistent stricture.

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Figure 18.2  (a) End of multiple stent trial, endoscopic view four stents. (b) Fluoroscopic view with four stents in place. (c) Stents removed with patent anastomosis.

with the Niti‐S ComVi stent, 51 patients after prior treatment and 11 patients as the first intervention. There was a 24% migration rate but only a 9.6% failure rate and 7.1% stricture recurrences. The results were no different between initial and secondary treatments [23]. There are considerable design differences in the mechanical forces exerted by the various metal stent designs, and a device that has high axial force may want to straighten after deployment, rather than conform to the shape of the biliary tree, and has the potential to imbed into the wall of the bile duct [25]. The issue of stent migration and complications during attempted stent extraction has been addressed by two studies [26, 27] using stents with anchoring fins to decrease the incidence of stent migration. A prototype stent with proximal anchoring fins (M.I. Tech, Seoul, Korea) was placed in 22 patients compared with the same device with a flared proximal end in 22 patients, all with benign biliary strictures [26]; there was no outward migration of the stents with flaps compared with 33% with the flared end. All of the stents were removed without difficulty and the stricture improvement was equal. Another study reported removing all of 37 stents without difficulty, but 3 patients with benign strictures developed secondary strictures, two in whom the stent was placed intraductal rather than transpapillary, and the stricture was at the area of the distal stent margin [27]. The issue is the caliber of the main duct above and below the stricture, and it is wise not to use a metal stent that is wider than the native duct [27]. Technical issues that have not been fully addressed are the fact that plastic stents come in a variety of calibers and lengths, where the metal stents come only in 8‐mm and 10‐mm diameters, and up to 10 cm in length. For some of the highest benign lesions, the 2‐cm cuff above the stenosis would only allow intraductal deployment, and the safety and success of extraction is a major issue. An unresolved issue is what constitutes adequate stricture resolution. One series with “maximal stent” placement had a goal of no discernable residual stricture [20], but there is no data to support this conclusion. Being able to pass an inflated balloon through the stricture, especially if the balloon is passed upstream, where there may be less tendency for deformity than when pulling downstream. The issue of duration of stenting is less established with concrete data, one study [16] demonstrated significantly improved stricture resolution at 8 months for fcSEMS compared with plastic stents for CP

18  Benign Biliary Strictures

and postsurgical benign strictures. A second study with fcSEMS alone came to the same conclusion that 8 months is sufficient [28]. One area that fcSEMS may pose and increased risk of a complication over other stenting methods is to cause cholecystitis if the cystic duct is covered [29]. This may be more of an issue in pancreatitis strictures because the gallbladder is absent in almost all transplant and most postsurgical patients. The results of expert surgery for post‐cholecystectomy strictures are also good. An early non‐randomized study comparing surgery versus one or two 10 F or 11.5 F stents reported similar long‐term outcomes, with higher early complications in the surgical group and more delayed complications after stenting [6]. Surgical repair is more problematic in patients with strictures after liver transplantation, where an initial endoscopic approach may be preferred [20]. Percutaneous transhepatic drainage and stenting may be valuable in some cases.

I­ nflammatory Strictures: Primary Sclerosing Cholangitis (PSC) and IgG4-Sclerosing Cholangitis (IgG4-SC) The diagnostic role of ERCP in PSC has diminished significantly in recent years because MRCP has now similar sensitivity and specificity and demonstrates the presence of dominant strictures, either intrahepatic (Figure 18.3) or extrahepatic (Figure 18.4a and b). It is also less costly than ERCP and without hazard [30]. A recent meta‐analysis involving 456 subjects compared MRCP to ERCP in four centers and to ERCP or PTC in another two [31]. The overall sensitivity was 86% and the specificity 91%. The problem is that IgG4‐SC can have similar magnetic resonance imaging (MRI) findings and the diagnosis may require ERCP with direct cholangioscopy or biopsy along with serologic finding of elevated levels of IgG4 levels [32]. Endoscopic treatment of dominant strictures seems logical in patients with significant cholestasis, but the long‐term value is unproven, and stenting carries the risk of cholangitis

Figure 18.3  Magnetic resonance cholangiogram with dominant stricture of left hepatic duct and normal common duct.

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Figure 18.4  (a) Magnetic resonance cholangiogram showing a tight common bile duct stricture (arrows), and (b) ERCP showing the stricture as well as biliary pseudo‐diverticulosis, classic for primary sclerosing cholangitis.

[33]. The Amsterdam group proposed stenting for only 1 to 2 weeks and reported symptomatic improvement in 83% and normalization of bilirubin levels in 12 of 14 patients at 2 months. Additionally, there was no reintervention in 80% at 1 year and 60% at 3 years [34]. The same group in a prospective randomized trial reported in abstract showed equal results with short‐term stents compared with balloon dilation but significantly less adverse events with balloon dilation (42% vs 10%) [35]. One report covered a 20‐year prospective evaluation of 171 patients with PSC treated by ERCP [34]. It was performed if the alkaline phosphatase was at least 2× the upper limit of normal and treatment with balloon dilation of dominant strictures that were 1.5 mm diameter or less in the common bile duct (CBD) and 1.0 mm in the intrahepatic ducts if they were within 2 cm of the bifurcation. A small sphincterotomy was performed, followed by sequential dilation up to 24F in the CBD (Figure 18.5a–c) and 18 F to 24 F in the intrahepatics. Dilation was repeated at 4‐week intervals until “success, as assessed by opening of the stenosis on repeat cholangiography” was achieved. A total of 97 patients underwent 500 dilations; 5 additional patients had stents placed for 1‐2 weeks after dilation for severe cholestasis with active clinical cholangitis. The procedural related complications were pancreatitis in 2.2%, bacterial cholangitis in 1.4%, and a single CBD perforation (0.2%) [36]. A later extension of this groups work was to offer patients with PSC an annual ERCP and repeating dilation if new or recurrent stricture occurred regardless of symptoms or laboratory findings. Those patients who refused this approach were treated only if clinically indicated [37], and this group was used as a retrospective “control” group for statistical analysis. They found that among those patients with dominant strictures, the annual ERCP group had a longer interval to transplant‐free survival (17.8 years vs 11.1 years) than the as‐needed group. This study report is neither randomized nor prospective.

18  Benign Biliary Strictures (a)

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Figure 18.5  (a) ERCP with main duct biliary stricture (arrow) and (b) stricture with 6‐mm balloon dilation. (c) Post dilation.

The goal of endoscopic therapy in PSC is to relieve symptomatic cholestasis and to delay the need for transplantation, but this is unproven, and treatment carries risks. Although balloon dilation may be safer than stent placement, the real question is when to intervene and whether that alters the course of the disease. The current recommendation is that endoscopic therapy should be primarily by balloon dilation for dominant strictures (with antibiotics for a minimum of 5 days post procedure), and that stenting (albeit short erm) be limited to cases where dilation cannot maintain duct patency [38]. Autoimmune cholangiopathy (i.e. IgG4‐SC) is an important differential with PSC, mostly because it responds well to glucocorticoid therapy. A combination of histology, radiology, and serology may be needed for the diagnosis [39]. An important issue is that there are ­several patterns of presentation. Type I is a dominant stricture in the distal CBD, which must be differentiated from pancreatic cancer and distal cholangiocarcinoma (Figure 18.6a–d). Type II has main CBD strictures mimicking PSC, and Type III and IV have prominent hilar ­strictures with cholangiocarcinoma being the main differential [39]. This points out the importance of tissue acquisition to obtain the right diagnosis in both IgG4‐SC and PSC and ERCP with cholangioscopy may be required (Figure 18.7a–d).

C ­ onclusions The use of therapeutic ERCP in the management of benign biliary strictures is now established practice, with a gradual transition from single to multiple stents and to various types of SEMS. Results are best in patients with postoperative biliary strictures (including post‐transplant), less so in patients with CP (especially with calcification), and essentially less used in PSC. Despite extensive experience and multiple cohort studies, there have

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Figure 18.6  (a) ERCP in Type I IgG4‐associated sclerosing cholangitis (IgG4‐PSC) with distal common bile duct stricture (arrow). (b) Endoscopic ultrasound image showing marked thickening of the common bile duct wall. (c) ERCP‐directed forceps biopsy. (d) Histology demonstrating marked lymphoplasmacytic infiltration of IgG4‐positive cells.

been no head‐to‐head comparisons of different stenting approaches or comparisons of endoscopy with surgery. Randomized trials would be ideal, but patients’ lesions and associated problems vary enormously. The lack of definitive trials makes it difficult to recommend the best approach. Prolonged plastic stenting with multiple plastic stents has the drawback of requiring multiple procedures, but the complications of the presence of the stents, once placed, is actually very low, and the stents are easily removed. The advantage of SEMS is the diminished number of procedures, with similar efficacy, but with some potential for complications from the stent itself. The use of fcSEMS seems to be the preferred method because of fewer procedures, equal results, and ease of removal. For the time being, the most prudent approach in patients with postoperative strictures seems to be to place a single plastic stent because many benign strictures will

18  Benign Biliary Strictures (a)

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Figure 18.7  (a) ERCP with common bile duct stricture (curved arrow) and obstruction of left hepatic duct (straight arrow). (b) ERCP cholangioscopy of the common bile duct showing irregular dilated vessels and biopsy was positive for inflammatory change. (c) ERCP with tight left hepatic duct stricture traversed (arrow). (d) ERCP cholangioscopy with total mucosal distortion and biopsy was positive for cholangiocarcinoma.

resolve quickly. The issue is what to do if the stricture persists when ERCP is repeated at about 3 months: Place multiple plastic stents, or consider metal stent insertion, and which one? No studies to date have produced the ideal stent. In PSC, until controlled data are available, it is perhaps best to minimize invasion; but balloon dilation is preferred to stenting. There are other considerations when deciding whether to offer endoscopic or surgical management in a particular case. Some patients (especially those with CP) are not compliant with prolonged treatments with stents (resulting in a significant risk of cholangitis), and the costs of repeated stenting are not insubstantial. There remain many questions as the field continues to evolve. The widespread availability of MRCP means that the patient’s problem can be identified easily and safely. The best

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approach should be discussed carefully in a multidisciplinary context before any invasive (and potentially hazardous) intervention is initiated. This should allow consultation with other relevant specialists and also detailed explanation to patients about their options. In some instances this should involve referral to a tertiary center because results of all the possible treatments in complex cases are operator‐dependent.

R ­ eferences 1 Soehendra N, Reynders‐Frederix V. Palliative bile duct drainage‐a new endoscopic method of introducing a transpapillary drain. Endoscopy 1980;8:8–11. 2 Speer AG, Cotton PD, MacRae KD. Endoscopic management of malignant biliary obstruction: stents of 10 French gauge are preferable to stents of 8 French gauge. Gastrointest Endosc 1988;34:412–417. 3 Smith AC, Dowsett JF, Russell RCG, et al. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet 1994;344:1655–1660. 4 Warshaw AL, Schapiro RH, Ferrucci JT Jr, et al. Persistent obstructive jaundice, cholangitis and biliary cirrhosis due to common bile duct stenosis in chronic pancreatitis. Gastroenterology 1976;70:562–567. 5 Deviere J, Devaere S, Baize M, et al. Endoscopic biliary drainage in chronic pancreatitis. Gastrointest Endsoc 1990;36:96–100. 6 Davids PHP, Tanka AKF, Rauws EAJ, et al. benign biliary strictures: surgery or endoscopy?. Ann Surg 1993;207:237–343. 7 Draganov P, Hoffman B, Marsh W, et al. Long term outcome in patients with benign biliary strictures treated endscopically with multiple stents. Gastrointest Endosc 2002,55;680–686. 8 Kahl S, Zimmermann S, Genz I, et al. Risk factors for failure of endoscopic stenting of chronic pancreatitis: a prospective follow‐up study. Am J Gastroent 2003;98:2448–2453. 9 Lawrence C, Romagnuolo J, Payne M, et al. Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals. Gastrointest Endosc 2010;72:558–653. 10 Deviere J, Cremer M, Baize M, et al. Management of common bile duct stricture caused by chronic pancreatitis with metal mesh self expandable stents. Gut 1994;35:122–126. 11 Yamaguchi T, Ishihara T, Seza K, et al. Long‐term outcome of endoscopic metallic stenting for benign biliary stenosis associated with chronic pancreatitis. World J Gastroent 2006;12:426–430. 12 van Berkel, Cahen DL, van Westerloo DJ, et al. Self‐expanding metal stents in benign biliary strictures due to chronic pancreatitis. Endoscopy 2004;36:381–384. 13 Familiari P, Bulajic M, Mutignani M, et al. Endoscopic removal of malfunctioning biliary self‐expandable metallic stents. Gastrointest Endosc 2005;62:903–910. 14 Cantu P, Hookey LC, Morales A, et al. The treatment of patients with symptomatic common bile duct stenosis secondary to chronic pancreatitis using partially covered metal stents: a pilot study. Endoscopy 2005;37:735–739. 15 Mahajan A, Ho H, Sauer B, et al. Temporary placement of fully covered self‐expandable metal stents in benign biliary strictures: midterm evaluation. Gastrointest Endosc 2009;70:303–309. 16 Cote A, Slivka A, Tarnasky P, et al. Effect of covered metal stents compared to plastic stents on benign biliary stricture resolution: a randomized clinical trial. JAMA 2016;315(12):1250–1257.

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1 7 Smits ME, Rauws EAJ, van Gulik TM, et al. Long‐term results of endoscopic stenting and surgical drainage for biliary stricture due to chronic pancreatitis. Br J Surg 1996;83:764–768. 18 Morelli J, Mulcahy HE, Willner IR, et al. Long‐term outcomes for patients with post‐liver transplant anastomotic biliary strictures treated by endoscopic stent placement. Gastrointest Endosc 2003;58:374–379. 19 Costamagna G, Tringali A, Mutignani M, et al. Endotherapy of postoperative biliary stricture with multiple stents: results after more than 10 years follow‐up. Gastrointest Endosc 2010;72:551–557. 20 Tabibian JH, Asham EH, Han S, et al. Endoscopic treatment of postorthotopic liver transplantation anastomotic biliary strictures with maximal stent therapy. Gastrointest Endosc 2010;71:505–512. 21 Chaput U, Scatton O, Bichard P, et al. Temporary placement of partially covered self‐ expandable metal stents for anastomotic biliary strictures after liver transplantation: a prospective, multicenter study. Gastointest Endosc 2010;72:1167–1174. 22 Triana M, Tarantino I, Barresi L, et al. Efficacy and safety of fully covered self‐expanding metallic stents in biliary complications after liver transplantation: a preliminary study. Liver Transplant 2009;15:1493–1498. 23 Marin‐Gomez LM, Sobrino‐Rodriguez S, Alamo‐Martinez JM, et al. Use of fully covered self‐expandable stent in biliary complications after liver transplantation: a case series. Transplant Proceed 2010;42:2975–2977. 24 Tarantino I, Mangiavilliano B, Di Mitri R, et al. Fully covered self‐expandable metallic stents in benign biliary strictures: a multicenter study on efficacy and safety. Endoscopy 2012;44:923–927. 25 Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial forces of biliary self‐expandable metallic stents. Gastrointest Endosc 2009;70:37–44. 26 Park DH, Lee SS, and Lee TH, et al. Anchoring flap versus flared end, fully covered self‐expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective comparative pilot study. Gastrointest Endoscop 2011;73:64–70. 27 Kasher JA, Corasanti JG, Tarnasky PR, et al. A multicenter analysis of safety and outcome of removal of a fully covered self‐expandable metal stent during ERCP. Gastrointest Endosc 2011;73:1292–97. 28 Mangiavillo B, Kashab MA, Eusebi LH, et al. Single brand, fully covered, self‐expandable metal stents for benign biliary disease: when should stents be removed? Minerva Gastroenterol Dietol 2019;65:63–69. 29 Jang S, Stevens T, Parsi M, et al. Association of covered metallic stents with cholecystitis and stent migration in malignant biliary obstruction. Gastrointest Endosc 2018;87:1071–1073. 30 Talwalkar JA, Angulo P, Johnson CD, et al. Cost‐minimization analysis of MRC versus ERCP for the diagnosis of primary sclerosing cholangitis. Hepatology 2004;40:39–45. 31 Dave M, Elmunzer BJ, Dwamena BA, et al. Primary sclerosing cholangitis: meta‐analysis of diagnostic performance of MR cholangiography. Radiology 2010;256:387–396. 32 Beuers U, Huber LM, Doorenspleet M, et al. IgG4‐associated cholangitis‐a mimic of PSC. Digest Dis 2015;33(supplement):176–180.

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3 3 van Milligen AWM, van Bracht J, Rauws EA, et al. Endoscopic stent therapy for dominant extrahepatic bile duct strictures in primary sclerosing cholangitis. Gastrointest Endosc 1996;44:293–239. 34 Ponsioen CY, Lam K, van Milligen AWM, et al. Four years experience with short term stenting in primary sclerosing cholangitis. Am J Gastroenterol 1999;94:2403–2407. 35 Ponsioen CY, Arnelo U, Bergquist A, et al. Multicenter randomized trial comparing short term stenting versus balloon dilation for dominant strictures in primary sclerosing cholangitis. J Hepatol 2017;66(supplement):S1–S2. 36 Gotthardt DN, Rudolph G, Kloters‐Plachky P, et al. Endoscopic dilation of dominant stenosis in primary sclerosing cholangitis: outcome after long‐term treatment. Gastrointest Endosc 2010;71:527–534. 37 Rupp C, Hippchen T, Btuckner T, et al. Effect of scheduled endoscopic dilation of dominant strictures on outcomes in patients with primary sclerosing cholangitis. Gut 2019;68:2170–2178. 38 Isayama H, Tazuma S, Kokudo N, et al. Clinical practice guidelines for primary sclerosing cholangitis. Curr Gastroenterol Rep 2018;53(9):1006–1034. 39 Kamisawa T, Nakazawa T, Tazuma S, et al. Clinical practice guideline for IgG4‐related sclerosing cholangitis. J Hepatobiliary Pancreat Sci 2019;26(1):9–42.

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19 The Role of ERCP in Pancreaticobiliary Malignancies John G. Lee H. H. Chao Comprehensive Digestive Disease Center, University of California at Irvine Medical Center, Irvine, CA, USA

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ERCP and stenting are indicated in most patients with malignant obstructive j­ aundice as a result of pancreatic cancer and in most patients with hilar obstruction. The number and location of stents placed for hilar obstruction should be based on magnetic resonance cholangiopancreatography (MRCP) and computed tomography (CT) findings with the goal being to drain at least 50% of the liver. Metal stents have similar efficacy, so availability and personal preference could ­dictate the choice of which stent to use.

­ERCP in Diagnosis of Pancreaticobiliary Malignancies ERCP is best used with endoscopic ultrasound (EUS) in the diagnosis and treatment of patients with pancreato‐biliary malignancies [1]. In my practice almost all patients with suspected cancer first undergo EUS and fine‐needle aspiration (FNA) for diagnosis and staging followed immediately by ERCP and stenting, and brush cytology or cholangioscopy and biopsy if FNA was suboptimal or not possible. EUS is done with the patient prone on the fluoroscopy table so it is easy to switch between the procedures.

Diagnosis of Cancer Visual appearance alone cannot be used to diagnose cancer, regardless of the imaging modality. A double duct sign on ERCP can be seen also in chronic pancreatitis, a mass on EUS can be seen in autoimmune pancreatitis, and an ulcerated stricture on cholangioscopy can be seen in stone disease (Figure 19.1). Therefore, a diagnosis of cancer requires either cytologic or pathologic confirmation. Tumors at or below the bifurcation are best diagnosed by EUS/FNA with ERCP and brush cytology reserved for intrahepatic strictures or in patients with primary sclerosing ERCP: The Fundamentals, Third Edition. Edited by Peter B. Cotton and Joseph W. Leung. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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Figure 19.1  A 70‐year‐old woman underwent cholangioscopy for evaluation of hemobilia seen during bile duct stone extraction. She had multiple large brown pigment stones removed in the past. (a) Cholangioscopy was performed using a pediatric gastroscope to obtain high‐definition images. (b) A friable ulcerated mass was seen in the intrahepatic duct. (c) Mucosal biopsies showed benign tissue without cancer. (d) Repeat cholangioscopy performed to obtain additional biopsies showed complete resolution of the ulcerated mass, leaving only a faint scar. Repeat biopsies were also negative for cancer, and the patient remains well on long‐term follow‐up.

cholangitis (PSC) who are potential transplant candidates (as prior FNA is an exclusion criterion in some transplant centers). Intrahepatic and proximal hilar tumors may not be seen or accessible by EUS; those patients need ERCP for diagnosis. ERCP brush cytology is about 40% sensitive for diagnosis of cancer. The sensitivity can be increased by using several different devices or performing multiple brushings (I usually do three), but the accuracy is still frustratingly low. Dilating the stricture prior to brushing has

19  The Role of ERCP in Pancreaticobiliary Malignancies

been reported to increase the diagnostic yield, as have different brush designs and ­materials. Although the false‐negative rate is too high for a negative result to exclude cancer, brush cytology is still often used to screen patients with PSC for occult cholangiocarcinoma. I perform three brushings from any involved areas, which typically adds up to six to nine brushings each time; I use a new brush when I sample a different area. Patients with any warning signs such as clinical deterioration, worsening appearance on magnetic resonance cholangiopancreatography (MRCP), or increasing cholestasis, need repeat examinations if the initial result is negative. Brush cytology can also be obtained from pancreatic strictures but is best avoided because of the risk of causing pancreatitis. Bile and pancreatic juice cytology and examination of cells from extracted stents have been used to diagnose cancer. Unfortunately, all these techniques are still less accurate than EUS FNA and should only be considered if there are no other diagnostic options. Biopsies can be taken directly in patients with ampullary cancer or polypoid biliary mucinous tumors. Fluoroscopically directed biopsies of the distal portion of a biliary stricture can be done after sphincterotomy using regular biopsy forceps, but I recommend doing so under direct vision using a video cholangioscope, taking at least six to seven specimens because of their small size. It is difficult to visualize the distal and proximal strictures on cholangioscopy, and it may be impossible to maneuver the scope through tight, angulated, or multiple strictures. Pancreatoscopy can be used in main duct intraductal papillary mucinous neoplasm (IPMN) to evaluate for cancer and to stage the extent of involvement, but the actual resection margin will be determined at the time of surgery so the results of pancreatoscopy rarely influence therapy. Various other diagnostic methods have been reported including optical biopsy techniques (e.g. endomicroscopy) and molecular and genetic analyses, but they are not useful in routine practice because administration of chemotherapy, radiation therapy, and cancer surgery almost always require cytological or histologic diagnosis. I do not use them nor recommend them outside of clinical studies.

­Palliation of Obstructive Jaundice in Pancreatic Cancer ERCP stenting is the best method for relieving jaundice in patients with pancreatic cancer. It is successful in >90% of patients with low morbidity and mortality. Although only surgery offers potential for cure, endoscopic palliation continues to remain the therapeutic goal in most patients because of the presence of metastatic or unresectable cancer, the plan for neoadjuvant therapy prior to surgery, or in patients unfit for major surgery.

Stenting ERCP stenting has been shown to be superior to surgical biliary bypass and has essentially replaced it. It has also been shown to have advantages over percutaneous biliary drainage, which is now used mainly when ERCP is not available or fails. Biliary stent technique. My approach is to use a 10 Fr plastic stent for the initial procedure, unless surgery has been definitely ruled out, because plastic stents cause the least

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inflammatory response in the biliary tract, according to our surgeons. I use a ­sphincterotome with a short hydrophilic guidewire for cannulation. I perform cholangiography only after successful passage of the guidewire into the proximal bile duct. I do not perform sphincterotomy or dilation before stenting. If initial cannulation yields the pancreatic duct, I perform precut sphincterotomy toward the biliary sphincter and place a 5 Fr pancreatic stent to reduce the risk of pancreatitis, followed by bile duct cannulation. I place an uncovered metal stent in patients with proven metastatic disease or severe comorbidities that preclude surgery. I exchange plastic stents every 3 months until the patient undergoes surgery or is determined to be clearly unresectable, at which point I exchange to an uncovered metal stent. Patients who develop recurrent jaundice after uncovered metal stent placement have a choice of either a plastic stent or another metal stent placed through the original stent. There are no data to show which approach is better. If the original metal stent provided long‐term patency (>9–12 months), then I use another metal stent, especially if the occlusion resulted from tumor ingrowth. If the original metal stent occluded shortly after placement or if it was the result of sludge or stones, then I clear the duct and place a plastic stent. A third alternative is to use a fully covered metal stent. If so, I use stents with large flanges (Gore Viabil, ConMed, Utica, NY) to prevent stent migration. Pancreatic strictures. Stenting a pancreatic duct stricture has been reported to relieve pain in pancreatic cancer, but I do not recommend it given its unproven efficacy, the risk of pancreatitis, and availability of other effective treatments, including celiac ganglion neurolysis and narcotic analgesics. Patients with a percutaneously placed internal external biliary drain. When desired, it is easy to replace the drain with an endoscopic stent; cannulate next to the drain, cut sutures securing the drain, cut the drain and remove it, and place the stent in the usual fashion. Patients who have an external drain only (i.e. the catheter is not in the duodenum) need either conventional ERCP or a guidewire can be passed through the biliary drain down to the duodenum for ERCP access. That is often more difficult than it sounds and risks dislodging the drain. Therefore, this method should only be used by teams well‐versed with guidewire manipulation and working with biliary drains. If ERCP stenting is unsuccessful. My approach is to immediately switch back to EUS for rendezvous procedure. EUS is used to puncture the common duct or intrahepatic duct with a FNA needle and aspirate bile to confirm correct position, followed by cholangiography and antegrade manipulation of a guidewire into the duodenum. Retrograde cannulation is then performed beside the EUS‐placed guidewire. If this fails, the guidewire can be pulled out through the duodenoscope and retrograde stenting performed. If antegrade manipulation of the guidewire fails, then EUS‐guided choledochoduodenostomy or hepatogastrostomy can be performed by dilating over the guidewire and placing a stent through the wall of the duodenum or stomach (Figure 19.2). EUS‐guided stenting has been shown to be safe and effective and is an important adjunct to conventional ERCP for palliation of malignant obstructive jaundice. Stent types. Comparative studies of plastic, uncovered, and covered metal stents have often shown conflicting results; a clear advantage has not been shown for any one type. For example, although metal stents are generally believed to last longer than plastic stents, one recent study showed no difference in patency between 10 Fr plastic stents and uncov-

19  The Role of ERCP in Pancreaticobiliary Malignancies (a)

(d)

(b)

(c)

(e)

Figure 19.2  A 50‐year‐old woman with metastatic breast cancer was referred for treatment of jaundice and duodenal obstruction. Prior attempt at ERCP failed because of inability to locate the ampulla within the stricture. (a) Endoscopic ultrasound (EUS) rendezvous was performed because the ampulla could not be found. The guidewire was passed antegrade after cholangiography. (b) An uncovered metal stent was back loaded over the wire and advanced to the bile duct. Partial deployment showed the stent not to cover the entire stricture, so the stent was removed with forceps. (c) Choledochoduodenostomy was performed. The EUS‐placed guidewire was left in place and a second guidewire was passed antegrade through the needle tract in the duodenal bulb into the intrahepatic duct. (d) Balloon dilation of the fine‐needle aspiration (FNA) needle tract was performed. (e) Endoscopy shows fully covered metal stent from the choledochoduodenostomy and the uncovered duodenal metal stent. The jaundice and nausea resolved within a week.

ered metal stents [2]. A covered metal stent is supposed to have longer patency compared to an uncovered metal stent, but another study showed the opposite results [3]. Many studies comparing metal stents are outdated in that the stents have been withdrawn, redesigned, or improved. Only a few studies have compared stents from different manufacturers. Finally, many institutions in the United States stock stents based on equipment contracts rather than objective evaluation. In my experience, uncovered metal stents usually seem to last longer than 10 Fr plastic stents. My personal preference for plastic stenting is to use a ­pliable stent (Sof‐Flex, Cook Endoscopy, Bloomington, IN) to avoid the risk

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of perforation from a migrated stent. I use 10 Fr stents only in pancreatic cancer. I use an uncovered 6.5  Fr metal stent (Zilver 635, Cook Endoscopy, Bloomington IN) in hilar tumors because it can be placed side by side through the duodenoscope. In conclusion, endoscopic palliation is highly successful, has a lower morbidity and mortality, and costs less compared to other palliative approaches to pancreaticobiliary malignancies.

Preoperative Stenting in Patients with Resectable Pancreatic Cancer Biliary decompression is usually required in patients with jaundice and pancreatic cancer before they can start neoadjuvant chemotherapy (e.g. administration of gemcitabine usually requires the bilirubin to be