Canadian Association of Gastroenterology Practice Guideline for clinical competence in diagnostic and therapeutic endoscopic retrograde cholangiopancreatography

This Practice Guideline is intended to assist individuals, training programs and credentialling bodies in understanding the training for and application of endoscopic retrograde cholangiopancreatography (ERCP), as well as in designating credentialling and maintenance of competence. The Canadian Association of Gastroenterology (CAG) Practice Guideline on training and credentialling provides the necessary background (1). Many of the principles outlined have been previously accepted by CAG (2). The American Society for Gastrointestinal Endoscopy (ASGE) (3,4) and the American College of Physicians (5) have previously formulated such guidelines. ERCP is a highly sensitive and technically challenging procedure for diagnosing and treating diseases of the biliary tract and pancreas. ERCP includes partial endoscopic evaluation of the upper gastrointestinal tract, particularly the ampulla of Vater and the second part of the duodenum, followed by cannulation of the ampulla and opacification, selectively if possible, of the biliary tree and/or pancreatic duct. It is recognized that this is an advanced endoscopic technique requiring previous comprehensive training in gastrointestinal disease. The trainee should have a solid basis of routine upper gastrointestinal endoscopy skills before being considered for training in ERCP. The highly invasive nature of ERCP and its greater risk of procedure-induced complications demand prudence in patient evaluation and greater technical skills. There are no short cuts in the acquisition of required skills although mechanical models and computer modelling may facilitate training (6). Nothing, however, will replace exposure to a large variety of clinical situations. With the use of ERCP, morbidity rates of 7% to 10% and mortality rates as high as 1.2% have been reported (7,8).

T his Practice Guideline is intended to assist individuals, training programs and credentialling bodies in understanding the training for and application of endoscopic retrograde cholangiopancreatography (ERCP), as well as in designating credentialling and maintenance of competence.The Canadian Association of Gastroenterology (CAG) Practice Guideline on training and credentialling provides the necessary background (1).Many of the principles outlined have been previously accepted by CAG (2).
The American Society for Gastrointestinal Endoscopy (ASGE) (3,4) and the American College of Physicians (5) have previously formulated such guidelines.
ERCP is a highly sensitive and technically challenging procedure for diagnosing and treating diseases of the biliary tract and pancreas.ERCP includes partial endoscopic evaluation of the upper gastrointestinal tract, particularly the ampulla of Vater and the second part of the duodenum, followed by cannulation of the ampulla and opacification, selectively if possible, of the biliary tree and/or pancreatic duct.It is recognized that this is an advanced endoscopic technique requiring previous comprehensive training in gastrointestinal disease.The trainee should have a solid basis of routine upper gastrointestinal endoscopy skills before being considered for training in ERCP.The highly invasive nature of ERCP and its greater risk of procedure-induced complications demand prudence in patient evaluation and greater technical skills.There are no short cuts in the acquisition of required skills although mechanical models and computer modelling may facilitate training (6).Nothing, however, will replace exposure to a large variety of clinical situations.
With the use of ERCP, morbidity rates of 7% to 10% and mortality rates as high as 1.2% have been reported (7,8).
Recognizing these risks, extensive initial training and regular ongoing experience are imperative to remain facile in this procedure and to minimize complications (personal communication, 9,10).
While learning the procedure, the trainee's performance must be directly supervised by an experienced endoscopist who regularly performs the procedure, and can adequately communicate to the trainee the information necessary to acquire these skills.An experienced endoscopist must subsequently evaluate the trainee; this should include written documentation of the experience of the trainee including the date, patient number, patient age, indication for the procedure, successful cannulation of each duct, duration of the procedure, findings and procedure complications (11).A log book should be maintained by each trainee, with the training endoscopist ideally initialling the log at regular intervals.
Recognition of both cognitive and technical aspects of training is expected.The trainee must be involved in the clinical evaluation of patients requiring ERCP in order to understand fully the clinical application of the procedure.In addition, the trainee should be involved in the care of patients following both uncomplicated and complicated ERCP.
Table 1 lists potential indications for ERCP.While no list is totally comprehensive, the majority of procedures should fulfil one of these criteria.These indications may change as technology changes.Potential contraindications to ERCP are listed in Table 2 but these may not be exhaustive.A number of situations arise in which ERCP is usually not helpful and generally not indicated.These are listed in Table 3.These indications and contraindications are intended to serve as a guideline, recognizing that such lists will never be all inclusive and need to be used with the clinical judgement of the experienced endoscopist and need to be updated with advances in medical care.Technical skills required to perform ERCP include a reasonable knowledge of the instrument and its care and disinfection; the ability to introduce, manipulate and withdraw the endoscope and allied instruments; and the ability to complete the procedure in an acceptable period of time with adequate patient comfort.These skills should result in the ability to cannulate the desired duct in at least 90% of attempts.It is expected that the endoscopist will ensure that appropriate equipment, nursing and technical staff, and other supportive services as necessary will be available.
Purely diagnostic ERCP by individuals unskilled in the application of therapeutic modalities in ERCP is inappropriate in the current clinical climate.Patients requiring investigation for the aforementioned clinical applications frequently will benefit from therapy that can often be applied endoscopically with greater safety and patient comfort than with other approaches.Clearly not all individuals who have undergone training in ERCP have acquired the necessary skills for treatment of all diseases encountered.However, the ability to relieve obstruction successfully when indicated and to remove stones when indicated has now become a required skill.A selection of common indications for therapeutic modalities in ERCP are listed in Table 5.

MINIMUM TRAINING STANDARDS Threshold for evaluation:
Numbers alone should never be the criterion for evaluation of training.However, the concept of a minimum 'threshold' of procedures that must be completed before the trainee may be evaluated has gained increasing acceptance (12).This concept is now validated for other endoscopic procedures (13)(14)(15) and for ERCP (16,17).
The ASGE previously suggested a minimum of 75 diagnostic procedures and 25 additional therapeutic procedures (18,19).However, objective evaluation of trainees suggested that these previously accepted numbers are too low.More recent data presented by Jowell et al (16), requiring a success rate of at least 80% in each of seven different criteria, confirm that at least 180 ERCP procedures are required to achieve technical competence in all components of ERCP.Many of these trainees had had prior ERCP experience and selected a career stream in therapeutic endoscopy (16).Data confirming that greater proficiency lead to better outcomes are not yet published.It is therefore advised that the performance of 180 ERCPs be the threshold for evaluation.
The ASGE has recently proposed that no minimal number of procedures be used; rather, that competence be defined as the ability to cannulate the desired duct selectively and freely at least 80% of the time without assistance (20).The learning process may progress at different rates for individuals, but there is evidence that surgical trainees acquire endoscopic skills no faster than medical trainees (13).It should be incumbent on the trainee to demonstrate success in all facets of ERCP in greater than 80% of attempts.Trainees and program directors should recognize that most trainees will require at least 180 procedures to achieve this level of competence.The mere completion of this minimum threshold number does not imply competence.A statement from the training endoscopist, in writing, based on the trainee's log should be required, indicating competence in different facets of endoscopy."It is the trainer's responsibility, both ethical and legal, to be certain that the physicians they certify are indeed competent in the certified skills" (21).Maintenance of competence: As noted above, regular performance of ERCP is necessary to maintain acquired skills.Infrequent performance of the procedure may lead to inappropriate application of the procedure, incorrect diagnoses and lower success rates with higher rates of complications.It is suggested that institutions catalogue all procedures as part of quality assurance programs so that review of outcomes may be facilitated if required.
Maintenance of competence requires an ongoing use of acquired skills.Again the number of procedures needed is difficult to apply rigidly; it was suggested in a survey of practicing gastroenterologists that a minimum of 50 procedures per year is required (22).
Granting of privileges should be applied in each institution by a multidisciplinary committee of members knowledgable in endoscopic procedures and their clinical usefulness and application."Today, hospitals have a duty to exercise due care in granting privileges to physicians, and they expose themselves to liability for granting specialized privileges to physicians/surgeons who are poorly trained, inexperienced with specific procedures, or insufficiently knowledgable about the relevant disease areas" (23).This process should also address the need for individuals with such skills in the institution (24,25).This issue has been addressed in another CAG Practice Guideline (1).Completion of a gastrointestinal or surgical fellowship alone does not imply acquisition of the necessary skills.Short courses in endoscopy offer inadequate hands-on experience and will not result in competence (26).
Proctoring may prove to be a useful technique to ensure that applicants have the necessary skills (25).

Table 4
(5)lines the cognitive skills necessary to assess competently the need for and application of ERCP(5).540 Can J Gastroenterol Vol 11 No 6 September 1997 Cockeram

TABLE 1 Potential indications for endoscopic retrograde cholangio- pancreatography
Evaluation of the patient with jaundice thought to be due to obstructionEvaluation of the patient with symptoms suggestive of disease of the biliary tree or the sphincter of Oddi