ERCP: The Fundamentals

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Section 1

Preparation

Chapter 1

Training and assessment of competence (Preparing the endoscopist)

Joseph Leung¹,² & Peter B. Cotton³

¹ Department of Gastroenterology and Hepatology, Davis School of Medicine, University of California, Sacramento, USA

² Section of Gastroenterology, VA Northern California Health Care System, GI Unit, Sacramento VAMC, Mather, USA

³ Digestive Disease Center, Medical University of South Carolina, Charleston, USA

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.

Background

ERCP is the most complex common endoscopic (digestive) procedure. It has great potential for benefits, but it also carries significant risk of failure, adverse events [1], and medico-legal 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 (and also endoscopic ultrasound). In the structured British National Health System, the number of training positions is now 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 upon training programs to ensure that those they train are able to reach an acceptable level of competence for safe independent practice.

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 gastrointestinal (GI) training programs, such as the 3-year fellowships in the United States.

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]. There are four levels (Table 1.1). Levels 1 and 2 together include the fundamental (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 higher-volume centers.

Table 1.1 Complexity levels in ERCP. Adapted from Cotton et al, 2011 [3]. Reproduced with permission of Elsevier.

These distinctions are clearly relevant to training. No one should be trained to less than competence at level 2. Whilst 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 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 the fact 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 20–30 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, since it is essential for therapeutic interventions. Incompetence in this aspect causes failure and increases the risk of postprocedure pancreatitis. Deep cannulation allows passage of guide wires to support sphincterotomy, stenting, and balloon dilation. Training in these basic steps should be delivered in stages. The trainer demonstrates the 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 and image interpretation. 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 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 incorporate the following: provide trainees with the learning opportunity to Improve their basic skills, Demonstrate realism to help trainees understand 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].

While ERCP practice on a live anesthetized pig offers the closest resemblance to the human setting, it is rarely used, since it is expensive, labor-intensive, and difficult to organize without special facilities, and carries potential ethical concerns. In general, three types of 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 accessories for therapeutic ERCP.

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

*Anatomical variation with pig stomach model; the papilla is close to the pylorus.

†Neopapilla modification allows for multiple papillotomy practices (up to three per papilla).

‡EMS is the only model with two randomized controlled trials; results showing improvement of trainees’ clinical performance with coached simulation practice.

§Live animal model allows for only one papillotomy per animal. Ex vivo model allows for only one papillotomy unless modified using the Neopapilla.

A more commonly used training model is the ex-vivo porcine stomach model with attached biliary system that allows trainees to practice with real scope and accessories [9]. However, the anatomical variation, that is, 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 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 utilize 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 guide wire 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.

Despite different simulators being available to supplement clinical ERCP training, and two prospective trials showing their value [15, 16], their use has been largely restricted so far to special teaching workshops.

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 in terms of technical operation as well as 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.

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 1.3–1.5.

Table 1.3 Some suggested simulator practice scores to evaluate trainees’ practice performance.

Table 1.4 Clinical assessment (to be filled in by trainer at completion of ERCP).

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

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

Overall assessment of current competence in standard ERCP skills (%):

Table 1.5 Trainer assessment score of trainees’ performance (five-point score).

Objective assessment of performance is easier to document with practice on simulators (Table 1.2). Specific end points 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 a different setup including changing position of the papilla or level of the bile duct stricture. Such changes can cater for procedures with varying levels of difficulties from basic cannulation to papillotomy and to the more advanced procedures such as multiple stents placement for a simulated bile duct stricture [17].

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 end points for measuring the quality of ERCP training and success with the procedure, but strictly speaking, these end points 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 and colleagues that showed that their trainees were only approaching 80% competency after 180–200 procedures [18]. The ASGE recommends that trainees should have performed 200 ERCP procedures with 80% success of cannulation with more than half of the procedures being therapeutic before they are considered competent or rather ready for assessment of competency [19]. The Australians have an even tougher criterion which requires trainees to have performed 200 successful solo procedures without trainer involvement [20].

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 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) [21], and have the opportunity to compare them with peers (benchmarking) [22]. 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. These systems need to be improved.

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 logbooks, videos, references, and observation of procedures (live and simulated) in their home environment or elsewhere. Ideally, there should be some form of certification at the 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 life-saving, 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 [21]. 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 [23].

Appendix

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

Cannulation

Understanding the use of contrast (different concentrations), priming the catheter and eliminating air bubbles, preparing a wire-guided papillotome (and if necessary, shaping the catheter or papillotome)

Able to achieve proper positioning with correct orientation and alignment with the axis for respective ducts for selective and deep cannulation of respective system, appropriate use of contrast injection, avoid overfilling of pancreas or obstructed biliary systems, and able to capture good radiograph for documentation

Guide wire manipulation

Understanding the use of different guide wires and their application, able to manipulate a guide wire with coordinated exchange of accessories, good control during exchange and avoid losing wire position, if necessary, able to shape tip of guide wire to negotiate difficult bile duct stricture, selective placement of guide wire in intrahepatic system and/or pancreatic duct

Dilation (rigid or balloon)

Understanding the use of rigid catheter dilator versus pneumatic balloons, understand how to fill insufflator with contrast and get rid of 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 under special circumstances

Cytology

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

Stenting

Understand the difference between straight versus double-pigtail stents, choice of stents, know and demonstrate how to measure stent length based on different methods, choice of guide wire for difficult stenting (intrahepatic bile duct (IHBD) stricture), special stent (for left hepatic duct) and proper deployment of stent (position and length), and able to deploy multiple stents in the common duct and right and left hepatic ducts

Basket

Understand the operation of different types of basket, 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 overinflating the balloon and know how to adjust balloon size 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 postpapillotomy bleeding and able to insert biliary stent to ensure drainage

References

1 Cotton PB. Complications of ERCP. In Cotton PB and Leung J. Eds. Advanced Digestive Endoscopy: ERCP, Blackwell Science, Massachusetts, MA, USA, 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 Cotton Ed. Advanced Endoscopy (e-book), Gastrohep.com, 2005: 1–50.

5 Leung J, Lim B. Training in ERCP. In Cohen J. Ed. Successful Training in GI Endoscopy, Wiley-Blackwell, Sommerset, NJ, USA, 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 Jul;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.

10 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 Jun; 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, Leung F. 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 JW, Lee W, Wilson R, et al. Comparison of Accessory Performance using a Novel ERCP Mechanical Simulator. Endoscopy 2008;40:983–988.

18 Jowell PS, Baillie J, Branch MS, et al. Quantitative Assessment of Procedural Competence. A Prospective Study of Training in Endoscopic Retrograde Cholangio-pancreatography. Ann Int Med 1996;125(12):983–989.

19 Baron T, Petersen BT, Mergener K, et al. Quality Indicators for Endoscopic Retrograde Cholangiopancreatography. Gastrointest Endosc 2006;63(4):S29–S34.

20 Conjoint Committee for Recognition of Training in Gastrointestinal Endoscopy. www.conjoint.org.au (accessed on July 31, 2014).

21 Cotton PB. How Many Times have you Done this Procedure, Doctor? Am J Gastroenterol 2002;97:522–523.

22 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.

23 Cotton PB. Are Low-Volume ERCPists a Problem in the United States? A Plea to Examine and Improve ERCP Practice-NOW. Gastrointest Endosc 2011 Jul;74(1):161–166.

Chapter 2

Preparing the facilities and equipment

Joseph Leung

Department of Gastroenterology and Hepatology, Davis School of Medicine, University of California, Sacramento, USA

Section of Gastroenterology, VA Northern California Health Care System, GI Unit, Sacramento VAMC, Mather, USA

Key points

An organized purpose-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 exchange with the long wire system.

Endoscopists should be familiar with the advantages of using short guide wire systems.

ERCP is a team event with many contributing elements. The key issues for endoscopists, trainees, nurses, anesthesia, radiology, and reporting are covered in separate chapters. Here we address 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 in 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 of the equipment and personnel (including anesthesia when needed). The layout may be such as to expose team members to more radiation than 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. In addition, it is tedious and inefficient to have to transport all of the potentially needed equipment for each case. The same issues arise when ERCP has to be done in other places, such as operating rooms and intensive care units.

The principal design features of a dedicated ERCP room and the main items of equipment are described.

The ERCP room should be large enough (at least 450 sq ft) to house all of 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, that is, the endoscopist(s) nurse/assistant(s), radiology tech, sedation/anesthesia staff, plus any trainees and observers (Figure 2.1).

Figure 2.1 Room setup and floor plan. A, assistant; E, endoscopist; S, sedationist.

Accessories should be organized and stored to facilitate easy retrieval during procedures (Figure 2.2).

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

The endoscopy and fluoroscopy monitors should be placed side by side (Figure 2.3) (or combined in one screen) and ceiling-mounted at eye level across the X-ray table (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 to scope displacement or straining of the 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.

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

Endoscopy tower/support system

The endoscopy support system includes the light source, video processor, and recording equipment. This is all best mounted on a beam 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, but is usually placed to the right of the endoscopist, with sufficient room left in between for the assistant to manipulate accessories.

Duodenoscopes

Video endoscopes are available from several manufacturers, mainly Olympus, Pentax, and Fujinon. We prefer to use the larger therapeutic endoscope with a 4.2-mm channel for most procedures in adults because it can accept the larger 10 Fr accessories. The smaller endoscope with a 3.2-mm channel can be used when luminal narrowing is expected, and in children above the age of two. 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 hepatico-jejunostomy. An upper 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 cholangioscopy to be performed by a single operator. Extralarge channel endoscopes are available for passage of baby choledochoscopes and pancreatoscopes.

The designs of the common duodenoscopes are broadly similar. One Olympus model incorporates a notch at the elevator (V-notch) that allows the elevator to grip the guide wire during exchange of accessories.

Accessories

The commonly used ERCP accessories are listed in Table 2.1 and are discussed here. Other more complex or advanced accessories and their applications will be described individually in the chapter on techniques.

Table 2.1 ERCP accessories.