Stricter national standards are required for credentialing of endoscopic-retrograde-cholangiopancreatography in the United States

Table 1 Literature review of criteria for endoscopic retrograde cholangiopancreatography privileging and practice

First author, Journal, Year study published	Type of study	Proposed Minimum number of ERCPs or other criteria for determining competence	Quality indicator or comments
Wigton et al[37], American College of Physicians, Ann Intern Med 1988	Position paper, American College of Physicians	35 supervised ERCPs. No quality indicators specified.	Document to include degree of success of ERCP. Types of ERCP not specified.
Watkins et al[38], Gastrointest Endosc 1996	Original prospective report of point at which GI fellow achieves 85% rate of cannulation of both pancreatic and bile ducts	100 supervised ERCPs	Point at which GI fellow achieves 85% rate of cannulation of desired duct (either pancreatic duct or bile duct)
Jowell et al[40], Ann Intern Med 1996	Prospective study involved grading of 1796 ERCPs among 17 GI fellows	180 supervised ERCPs	Number of ERCPs for individual skills: 160 for cholangiography, 160 for pancreatic duct cannulation, 120 for stone extraction, and 60 for stent insertion.
Eisen et al[41], Gastrointest Endosc 2002	Position paper, American Society for Gastrointestinal Endoscopy	180 supervised ERCPs	80% ability to cannulate the duct of interest (either bile duct or pancreatic duct)
Garcia-Cano[39], Surg Endosc 2007	Letter to editor based on personal experience as surgeon training in ERCP	200 ERCPs	Based on personal experience at point at which achieved 80% rate of cannulation of bile duct. Anecdotal evidence.
Verma et al[43], Gastrointest Endosc 2007	Retrospective review of single operator ERCP learning curve	> 80% rate of successful deep cannulation of bile duct	Achieved at performing 350-400 ERCPs
Shahidi et al[42], Gastrointest Endosc 2015	Systematic review encompassing 9 studies	Competency achieved after 79 to 300 ERCPs, depending upon learning curve of individual trainee	Competency for specific quality indicators: 70 to 160 ERCPs for pancreatic duct cannulation, and 160 to 400 ERCPs for deep bile duct cannulation
Cotton[26], Gastrointest Endosc 2015	Editorial	Supports guidelines set by Australian Conjoint Committee of 200 ERCPs	To include a minimum of 80 sphincterotomies with intact papillary sphincters, and a minimum of 60 stents
Adler et al[44], Gastrointest Endosc 2015	Position paper, American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee	> 90% rate of deep cannulation of duct of interest with native papilla, > 90% rate of extraction of common bile duct stone < 1 cm in patient with normal bile duct anatomy, > 90% successful stent placement in patient with normal anatomy	---
Ekkelenkamp et al[47], Endoscopy 2015[47]	Nationwide analysis of 8575 ERCPs by 171 endoscopists in Holland during 1 yr.	Overall rate of “successful” ERCPs was 83.4% for native papilla and 89.4% after sphincterotomy.	Provides a reasonable estimate of expected success rate for ERCP operators.
Wani et al[48], Gastrointest Endosc 2016	Prospective multicenter trial conducted among 5 advanced GI endoscopy fellows at 5 medical centers	Number of ERCPs to achieve successful cannulation rate > 90% of biliary duct varied from 26 to 211 ERCPs.	Demonstrates variability in learning curves to achieve competence in ERCP as determined by > 90% rate of bile duct cannulation
Wani et al[49], Clin Gastroenterol Hepatol 2017	Prospective multicenter study of 22 advanced GI endoscopy trainees at 20 medical centers	Demonstrated substantial variability in learning curves for cognitive and technical ability in ERCP. This suggests basing criteria for competence not on volume, but on achieving landmarks for quality indicators (e.g., successful cannulation rate).	Variable learning curves for achieving cognitive and technical success in ERCPs upon completion of advanced endoscopy fellowship
Wani et al[45], Gastrointest Endosc 2018	Gastrointestinal Endoscopy white paper	Developed comprehensive data collection and reporting tool for assessing ERCP performance	Demonstrated feasibility of using a central database to monitor GI fellow performance
Faulx et al[50], Gastrointest Endosc 2017	American Society for Gastrointestinal Endoscopy Standards of Practice Committee Guideline	200 supervised ERCP procedures for assessing competency. Additionally, independently perform > 80 sphincterotomies and > 60 biliary stent placements
Wani et al[53], Gastroenterology 2018	Prospective multicenter clinical trial involving 22 advanced GI endoscopy fellows	After completing an advanced endoscopy fellowship, ERCP operators achieved an average successful cannulation rate of 94.9% in private practice.	This work shows that advanced endoscopy fellowship training leads to successful ERCP performance in private practice.
Cotton[60], Gastrointest Endoscopy 2017	Survey of 1126 responding United States gastroenterologists	No written guidelines for initial ERCP credentialing-21%. No written guidelines for repeat credentialing process-54%.	Urgent need to improve credentialing process.
Cassani et al[63], Gastrointest Endosc 2017	Editorial on sorry state of ERCP credentialing	“Despite repeated studies, editorials, gastroenterology society papers, credentialing committees have yet to take the initiative and require increased scrutiny for both hospital and (ERCP) procedural outcomes.”	Frank discussion of current failures in credentialing process.
Wani et al[4], Gastrointest Endoscopy 2019	Prospective multicenter study determining standards for competency for ERCP based on learning curves for 37 advanced endoscopy fellows in 32 programs.	Advanced endoscopy fellow required an average of 226 ERCPs to achieve competency in native papillary cannulation, and required an average of 120 sphincterotomies to achieve competency in biliary sphincterotomy.	Provides guidance on threshold number of ERCPs at which to assess competency.

ERCP: Endoscopic retrograde cholangiopancreatography; GI: Gastrointestinal.

Table 2 Core Curriculum for endoscopic-retrograde-cholangiopancreatography trainees

Cognitive
1 Obtain written, witnessed, and informed patient consent with discussion of the indication for the ERCP; potential complications including pancreatitis, hemorrhage, duct leak, perforation and infection; alternative tests or therapies; and adequately answer patient questions
2 Realize appropriate indications for ERCP and accessory interventions
3 Evaluate patient prior to procedure and optimize outcomes, in terms of potential bleeding (i.e., hold antiplatelet and anticoagulants if possible), and administer antibiotics as necessary to prevent subsequent sepsis
4 Understand and practice prophylactic interventions, especially to prevent post-ERCP pancreatitis
5 Know “best practice” recommendations as to technical approaches during ERCP
6 Knowledge of optimal management of ERCP complications
7 Manage the patient after ERCP as in-patient or outpatient, as appropriate
8 Manage complications occurring during or after ERCP
9 Knowledgeably discuss findings and consult with allied specialists: hepatobiliary or pancreatic surgeons and interventional radiologists
Technical (not comprehensive)
1 Evaluate ampulla in a knowledgeable fashion
2 Access necessary ductal system via deep cannulation ≥ 90% attempts
3 Procure required fluoroscopic images of the biliary and pancreatic ductal systems
4 Working knowledge to interpret fluoroscopic images
5 Perform optimal biliary and/or pancreatic sphincterotomy as required
6 Extract biliary and pancreatic duct stones via basket or balloon.
7 Insert plastic and metal stents into pancreatic and biliary system as required
8 Perform intraductal endoscopy and associated diagnostic or therapeutic maneuvers, as required: EHL, laser, biopsies, and brushings

Adopted with major modifications from Jorgensen et al[23]. ERCP: Endoscopic retrograde cholangiopancreatography; EHL: electrohydraulic lithotripsy.

Table 3 Ongoing controversies in endoscopic-retrograde-cholangiopancreatography training and privileging

Ongoing controversies in endoscopic-retrograde-cholangiopancreatography training and privileging
1 What minimum number (if any) of ERCPs should be performed during a dedicated advanced training fellowship to justify credentialing?
2 What minimum number of ERCPs should be documented by a physician who seeks credentialing in ERCP after completing a standard 3 yr GI fellowship?
3 What should the profile of submitted ERCPs consist of in terms of therapeutic interventions?
4 Should all new physicians granted ERCP privileges have a probation period with monitoring by a proctor, and if so for how long?
5 What criteria, other than numbers, should be used to assess competency in ERCP?
Cannulation of desired duct(s)
Procedure outcome
Patient outcome
Complication rate
Monitoring of ERCPs during a probation period.
6 Should administrators of standard gastroenterology fellowship training programs that are 3 yr long be allowed to certify GI fellows in ERCP or should credentialing be restricted only to GI fellows who have completed an extra year of advanced endoscopy training?
7 Is post-training proctoring acceptable as a means to attain ERCP competency?
8 Should EUS training be mandatory for ERCP performance?
9 Should advanced GI fellowship training programs offer only a dedicated EUS or ERCP pathway but not both?
10 Should curriculum content for advanced therapeutic training be nationally standardized? Are there a sufficient number of advanced GI endoscopy program fellowships and are they of sufficient duration?
11 Should manpower concerns affect ERCP credentialing or should standards for competency be the only consideration?
12 Should individual hospital needs for ERCP operators affect credentialing?
13 Should all ERCP practitioners be compelled to participate in an on-call rotation for emergency ERCPs to be performed at night or on weekends?
14 Should all GI endoscopists with staff privileges for ERCP be compelled to join a rotation to perform ERCPs on public uninsured patients?
15 Should all ERCP practitioners be required to perform a minimum number of ERCPs per annum to maintain ERCP privileges (proficiency)? If so, what is the minimum number: 25 or 50 ERCPs per annum?
16 Should a national board exam, similar in concept to the examination in Gastroenterology by the American Board of Medicine be required for certification in ERCP to assess cognitive knowledge in ERCP and related clinical disciplines?

ERCP: Endoscopic retrograde cholangiopancreatography; GI: Gastrointestinal.

Table 4 Grading System for endoscopic-retrograde-cholangiopancreatography difficulty

Grading system for ERCP
Grade I
Deep cannulation of CBD or main pancreatic duct
Extraction of small-to-medium (≤ 10 mm) biliary stones
Biliary stenting for leaks
Grade II
Treatment of extra-hepatic benign or malignant ductal strictures
Placement of prophylactic pancreatic stents
Extraction of larger biliary stones
Grade III
Pancreatic stricture dilation and stenting
Removal of mobile pancreatic stones ≤ 5 mm
Hilar tumor stenting
Treatment of hilar and intrahepatic biliary stricture
Sphincter of Oddi manometry
Limited pancreatic sphincterotomy
Removal of migrated pancreatic stents
Grade IV
Removal of impacted and larger pancreatic stones
Pseudocyst drainage or necrosecetomy
Ampullectomy
ERCP in patient with altered anatomy (e.g., status post Billroth II surgery)
Minor papilla therapy
Grade V
“Rendezvous” procedure to access and stent the biliary and pancreatic systems - requires endoscopic ultrasound training

Adapted with modifications from Cotton[3]. ERCP: Endoscopic retrograde cholangiopancreatography; CBD: Common bile duct.

Table 5 Determining competency for endoscopic-retrograde-cholangiopancreatography

Duties of GI fellow applying for ERCP privileges at a hospital	Duties of GI supervisor of ERCP training/GI fellowship program director	Duties of hospital committee voting on ERCP privileges for applying physician
Contemporaneously sign each ERCP note in which actively participated	Ascertain GI fellow signs ERCP notes when the fellow actively participated in case
Can contemporaneously sign each note in which merely observed ERCP, but observer status should be reflected in note	Allow fellow to sign on note as an observer (not active participant) in cases in which fellow was passive observer	Passive observation of an ERCP should be meaningful in enhancing cognitive skills for ERCP, but cannot count towards minimum threshold for performed ERCPs
ERCP note in which GI fellow participated should specify what technical procedures performed during ERCP: e.g., sphincterotomy, stone extraction, dilation of stenosis, and etc.	Ascertain that endoscopy report includes all technical aspects of the performed ERCP	Ascertain that received data is complete
Collate all numbers performed for ERCP: Number performed, number (%) cannulated, number with sphincterotomy, number with stone retrieval, number of strictures dilated, and etc.	Review total numbers of ERCPs and number of ERCPs in which special techniques were employed as appropriate. Record rate (%) of success of special techniques.	Review total numbers of ERCPs and number (%) of ERCP special procedures and determine whether these data satisfy minimal numbers and minimal % of successful result required for competency
Make sure packet with ERCP numbers and recommendations is submitted in a timely manner at hospital applicant is applying for ERCP privileges	Sign form containing total number of ERCPs, and write whether GI fellow is recommended for independent privileges in ERCP	Decide in a timely manner whether physician granted ERCP privileges. If decision is negative, provide internal due process to appeal decision

Duties of graduating gastrointestinal fellow, endoscopic-retrograde-cholangiopancreatography supervisors during fellowship training, and credentialing committee at hospital to which applicant is applying for endoscopic-retrograde-cholangiopancreatography privileges. ERCP: Endoscopic retrograde cholangiopancreatography; GI: Gastrointestinal.

Table 6 Proposed standardized gastroenterology fellowship report card for endoscopic-retrograde-cholangiopancreatography training and performance

Proposed standardized gastroenterology fellowship report card for ERCP
Achievements:
______ Number of ERCPs in which trainee was only a passive observer.
______ Number of ERCPs in which trainee actively participated (excludes ERCPs in which trainee was only a passive observer)
______ Number and ______% of ERCPs in which trainee personally successfully cannulated at least one duct (includes either common bile duct or pancreatic duct)
______ Number and ______% of ERCPs in which trainee personally successfully performed sphincterotomy
______ Number and ______% of ERCPs in which trainee successfully personally performed stone retrieval by basket or balloon pull through
______ Number of ERCPs in which trainee successfully dilated a biliary or pancreatic stricture
______ Number of ERCPs in which trainee successfully personally deployed a stent
______ Number of ERCPs in which trainee successfully retrieved a stent
______ Number of ERCPs in which trainee successfully used daughter endoscope (e.g., Spyscope) technology
Adverse events:
Number and percent of total ERCPs in which trainee participated in which adverse events occurred:
For fatal complication: Number_____ Percent of total ______
For major adverse events: Number ______ Percent of total ______
For minor adverse events: Number ______ Percent of total ______
Has the trainee been a defendant in a medical malpractice suit in any ERCP in which the trainee participated? _____ Yes ______ No.
Has the trainee had privileges in ERCP revoked or restricted or received a written warning? _____Yes _______No
Has the trainee voluntarily given up ERCP privileges in lieu of these privileges being revoked or restricted? ___Yes ______No

ERCP: Endoscopic retrograde cholangiopancreatography.