Mitchell S Cappell, David M Friedel

Abstract Endoscopic-retrograde-cholangiopancreatography (ERCP) is now a vital modality with primarily therapeutic and occasionally solely diagnostic utility for numerous biliary/pancreatic disorders. It has a significantly steeper learning curve than that for other standard gastrointestinal (GI) endoscopies, such as esophagogastroduodenoscopy or colonoscopy, due to greater technical difficulty and higher risk of complications. Yet, GI fellows have limited exposure to ERCP during standard-three-year-GI-fellowships because ERCP is much less frequently performed than esophagogastroduodenoscopy/colonoscopy. This led to adding an optional year of training in therapeutic endoscopy. Yet many graduates from standard three-year-fellowships without advanced training intensely pursue independent/unsupervised ERCP privileges despite inadequate numbers of performed ERCPs and unacceptably low rates of successful selective cannulation of desired (biliary or pancreatic) duct. Hospital credentialing committees have traditionally performed ERCP credentialing, but this practice has led to widespread flouting of recommended guidelines (e.g., planned privileging of applicant with 20% successful cannulation rate, or after performing only 7 ERCPs); and intense politicking of committee members by applicants, their practice groups, and potential competitors. Consequently, some gastroenterologists upon completing standard fellowships train and learn ERCP “on the job” during independent/unsupervised practice, which can result in bad outcomes: high rates of failed bile duct cannulation. This severe clinical problem is indicated by publication of ≥ 12 ERCP competency studies/guidelines during the use is non-commercial. See:http://creativecommons.org/licen ses/by-nc/4.0/Manuscript source: Invited manuscript Received: February 27, 2019 Peer-review started: February 27,2019 First decision: May 9, 2019 Revised: May 16, 2019 Accepted: June 23, 2019 Article in press: June 23, 2019 Published online: July 21, 2019 P-Reviewer: Kitamura K S-Editor: Yan JP L-Editor: A E-Editor: Wang J last 5 years. However, lack of mandatory, quantitative, ERCP credentialing criteria has permitted neglect of recommended guidelines. This work comprehensively reviews literature on ERCP credentialing; reviews rationales for proposed guidelines; reports problems with current system; and proposes novel criteria for competency. This work advocates for mandatory, national, written,minimum, quantitative, standards, including cognitive skills (possibly assessed by a nationwide examination), and technical skills, assessed by number performed (≥ 200-250 ERCPs), types of ERCPs, success rate (approximately ≥ 90%cannulation of desired duct), and letters of recommendation by program director/ERCP mentor. Mandatory criteria should ideally not be monitored by a hospital committee subjected to intense politicking by applicants, their employers, and sometimes even competitors, but an independent national entity,like the National Board of Medical Examiners/American Board of Internal Medicine.

Key words: Endoscopic retrograde cholangiopancreatography; Privileges; Credentialing;Gastroenterology fellowship training; Advanced gastrointestinal endoscopy training;Certification; Standards

INTRODUCTION

Endoscopic retrograde cholangiopancreatography (ERCP) compared to the other standard gastrointestinal (GI) procedures of esophagogastroduodenoscopy (EGD)and colonoscopy is technically far more difficult, requires greater skill, and entails a higher rate of clinically significant complications. Yet GI fellows have limited exposure to ERCP during a standard three years GI fellowship because ERCP is much less frequently performed than EGD or colonoscopy. This combination of a steep learning curve and limited exposure motivated the institution of an optional extra year of advanced endoscopy training, primarily devoted to ERCP but also devoted to endoscopic ultrasound (EUS). Yet many graduates from standard three years fellowships without an extra year of advanced training intensely pursue independent(unsupervised) ERCP privileges[1]. Sometimes these requests are reasonable, but they may be unjustified if the applicant did not perform an adequate number of ERCPs during standard fellowship training and has a low rate of successful selective cannulation of the desired (biliary or pancreatic) duct[1-3]. At least 18 studies,recommended guidelines, and editorials on ERCP credentialing have been published in the last 30 years, including 12 published since 2015 (Table 1). However, lack of mandatory, quantitative, written, criteria for ERCP credentialing has permitted ambiguities and neglect of recommended guidelines. Consequently, some gastroenterologists upon completing standard fellowship training learn ERCP “on the job” during independent unsupervised practice, which can result in bad ERCP outcomes: Extremely high rates of failed bile duct cannulation which necessitates that patients undergo repeat ERCP by another gastroenterologist at another time[2].

Fifty years after the institution of ERCP in 1968, this opinion piece calls for establishment of mandatory, written, and quantitative national criteria to prevent ambiguities and disregard of recommended guidelines. The monitor of the mandatory criteria should not ideally be an in-hospital committee because this committee is subject to intense political pressure by the applicants themselves and their employers(personal unpublished data, Cappell as Chief of Gastroenterology and Hepatology for last 12 years), but a truly independent entity. This work suggests consideration of establishing an independent national board, similar to the National Board of Medical Examiners or American Board of Internal Medicine, to maintain uniform national standards divorced from political pressure by local applicants, their private practice groups, competing gastroenterology groups, or hospitals. This work reviews prior recommended criteria for ERCP credentialing and their rationale; the compelling need for quantitative, mandatory criteria; and provides an example of mandatory credentialing criteria, which are merely illustrative because criteria should be established by consensus of a committee of ERCP experts preferably assembled under the auspices of the American Society of Gastrointestinal Endoscopy (ASGE), or similar professional GI organization.

METHODS

Literature on ERCP credentialing and training was comprehensively searched by computer using PubMed and Ovid with the following medical subject headings/keywords: (“ERCP” OR “endoscopic retrograde cholangiopancreatography” OR “endoscopic retrograde cholangiography”) AND (“privileges” OR“privileging” OR “credentials” OR “credentialing” OR “guidelines” OR “position paper” OR “recommendation” OR “American Society for Gastrointestinal Endoscopy” OR “ASGE” OR “competence” OR “competency” OR “competent” OR“training” OR “trainee” OR “quality” OR “independent practice”). The two authors independently performed literature searches, and decided on which articles to incorporate into this review according to appropriateness of article content and article priority based on consensus. This review was rendered up-to-date by repeating a computerized literature search just before submitting this work for publication which identified one new article just e-published ahead of print one week before submission of this opinion piece[4].

This work is restricted to privileging of adult gastroenterologists for ERCP in the United States because practice patterns, standards of care, and medical malpractice litigation patterns differ in the rest of the world; and excludes ERCP credentialing for pediatric gastroenterologists, or GI, hepatobiliary, and pancreatic surgeons because they have different practice patterns.

RESULTS

History and clinical significance of ERCP

ERCP is currently the procedure of choice for many biliary and pancreatic disorders.About 350000-500000 ERCP's are currently performed annually in the United States[3,5]. Common indications include choledocholithiasis, obstructive jaundice,biliary pancreatitis, malignant biliary obstruction, and benign biliary strictures; while uncommon indications include recurrent pancreatitis of unknown etiology, biliary or pancreatic duct leaks, pancreatic stones, pancreatic strictures, chronic pancreatitis,and sphincter of Oddi dysfunction[6,7].

After William McCune, an obstetrician, performed the first ERCP in 1968, Peter Cotton, a gastroenterologist, reported a clinical series of 60 diagnostic ERCPs in 1972[8]. Critical developments in diagnostic ERCP technology included side-viewing endoscopes to view the mural papilla en face, cannulation catheters, endoscopic elevators to facilitate papillary cannulation, guide-wires, biopsy forceps, and brushes.Classen and Demling in Germany[9], and Kawai and colleagues in Japan[10], pioneered ERCP therapy using sphincterotomes to open the ampulla and endoscopic devices to extract choledocholithiasis. ERCP has become increasingly therapeutic because of critical advances in therapeutic technology, including sphincterotomes for sphincterotomy, inflatable balloons or stents to dilate strictures, electrocautery to stem hemobilia, and baskets or inflatable balloons to retrieve choledocholithiasis.

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

ERCP: Endoscopic retrograde cholangiopancreatography; GI: Gastrointestinal.

Therapeutic ERCP often produces dramatic cures of life-threatening conditions, and is less invasive and safer than surgical options for various disorders, such as ascending cholangitis from choledocholithiasis[11]. ERCP therapies have largely obviated surgery for choledocholithiasis and choledochal strictures, and can improve survival in patients with cholangiocarcinoma[12,13]. The relatively recent change of ERCP to become a predominantly therapeutic modality has also been fostered by development of less invasive and safer pancreatico-biliary diagnostic tests than ERCP, including EUS and magnetic resonance cholangiopancreatography (MRCP).

ERCP entails greater risks of clinically significant complications than other standard GI endoscopic procedures, such as EGD or colonoscopy[14]. ERCP has a reported mortality ranging from 0.2%[15]to 1%[16], depending upon patient age,medical status, and planned therapeutic intervention. Kalaitzakis et al[17]reported a dramatic 12% mortality at 3 mo from post-ERCP pancreatitis, though patient-related factors, including cancer diagnosis and advanced age were contributing factors.Moreover, ultimately fatal post-ERCP pancreatitis is probably under-reported[18-20].Life-threatening complications after ERCP and sphincterotomy include postsphincterotomy bleeding, unremitting cholangitis, bile leak, and duodenal perforation. ERCP is a relatively common cause of medical malpractice litigation against gastroenterologists, and engenders a much higher rate of medical malpractice suits than other GI endoscopic procedures[21].

ERCP is uncommonly performed relative to the other two standard GI endoscopic procedures of EGD and colonoscopy. For example, at William Beaumont Hospital in Royal Oak, one of the ten largest hospitals in the United States, ERCP represents only about 700 (3%) of a total of 24000 annual GI endoscopies. Moreover, this percentage probably overestimates its relative frequency in the United States because this tertiary hospital is a referral center for ERCPs. The technically demanding skills and relatively high risks of severe complications of ERCP vs. relatively infrequent exposure to ERCP during standard three years of GI fellowship prompted gastroenterologistadministrators to establish a year of advanced endoscopy fellowship training primarily devoted to ERCP. Advanced endoscopy programs also generally incorporate training in diagnostic and therapeutic EUS, and increasingly offer other relatively recently introduced advanced endoscopic procedures, including: Double balloon enteroscopy, ablation therapy for Barrett's mucosa, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomoy,endoscopic clips to close GI perforations, endoscopic suturing, and peroral cholangiopancreatoscopy. Advanced GI fellows also need to generate clinical income by performing routine EGDs and colonoscopies because their salaries are not funded by Medicare. Training in these other advanced techniques and performance of routine GI endoscopies can adulterate the advanced fellowship experience in ERCP. The core curriculum outlines ERCP trainee goals in terms of expectations and experiences[22,23](Table 2). In one survey, graduating advanced fellows were generally satisfied with their advanced endoscopy training, but some of them would have skipped the extra year of advanced training altogether if they had more exposure to ERCP and EUS during their standard GI fellowship[24].

History and rationale of ERCP credentialing criteria

After the introduction of diagnostic ERCP in 1968 and therapeutic ERCP in 1974,clinical demand for ERCP burgeoned with scant regulation of ERCP privileges because of a severe shortage of endoscopists trained and proficient in this novel procedure. Cappell vividly recalls how Jerry Siegel, a highly talented pioneer clinical ERCP practitioner, travelled to numerous major academic hospitals throughout New York City totting a briefcase containing his own ERCP endoscope and endoscopic accessories to perform ERCP on referred patients, after being granted temporary,emergency, ERCP privileges at these hospitals. This lightly regulated “Wild West” of“have ERCP scope will travel” was prevalent in the mid-to-late 1970s[25]. Notable other ERCP pioneers included Peter Cotton at Duke University Hospital who has become the primary advocate of tighter regulation of ERCP privileges, Meinhard Classen in Germany, and Ito in Japan.

Table 2 Core Curriculum for endoscopic-retrograde-cholangiopancreatography trainees

Now 50 years after its inauguration, mandatory, written, and strict regulations of training and credentialing of ERCP, based on national guidelines, should be adopted.Regulation is required because of: (1) High risks inherent to ERCP, especially of post-ERCP pancreatitis, bile leaks, and post-sphincterotomy bleeding; (2) Extremely high level of technical expertise and cognitive skills needed to master therapeutic ERCP,especially given the ever increasingly innovative and more sophisticated therapeutic technologies; and (3) Diverse ERCP training backgrounds of applicants for ERCP privileges. As GI Division Director, Dr. Cappell and the Credentials Committee members have “denied” five applicants' applications for ERCP privileges because of insufficient documentation of ERCP training during their standard three year GI fellowship, low rate of bile duct cannulation, or request to perform ERCP at this tertiary university hospital while primarily based at a satellite hospital without arranging for emergency coverage to handle post ERCP emergencies on their patients at the academic teaching hospital. Indeed, one GI attending was denied ERCP privileges at a major academic hospital because of an extremely low volume of ERCP during a standard three year GI fellowship, and only a 20% rate of biliary cannulation afterwards in clinical practice[2]. Cotton[26]reported in 2015 that one GI fellow upon entering private GI practice was requested to join the ERCP rotation after having performed precisely 7 ERCPs during a standard three year GI fellowship.Contrariwise, applicants may be granted ERCP privileges despite inadequate training during a standard three years GI fellowship due to political pressure from a prominent GI group that the applicant is joining (Cappell, personal unpublished data). Such credentialing problems are exceedingly rare for other endoscopic procedures (Cappell, personal experience as Chief of Gastroenterology and Hepatology at an academic medical center during the last 12 years).

Concerns regarding ERCP training, competency, standard of practice, and credentialing began to appear in the literature about 25 years after its introduction[27,28].At the time, few medical institutions offered one year advanced endoscopy training programs focused on diagnostic and therapeutic ERCP after standard GI fellowship.Graduating GI fellows who did not train via this extra year were still eligible to obtain ERCP privileges if they had adequate training and experience during the standard three years of GI fellowship, pursued extra training abroad, or simply were selftrained. The landscape began to change around the new millennium as advanced training programs became relatively common. About 66 advanced endoscopy training programs currently exist in the United States. Concurrently, administrators of advanced endoscopy fellowships formulated a core curriculum to help standardize ERCP training and practice[22,29]. The ASGE has resolved that competency in ERCP is not required during standard GI fellowship training, and strongly recommended advanced endoscopy fellowship training to achieve clinical competence in ERCP[22,30].Despite these recommendations, a survey of GI fellows graduating from standard three year GI fellowships reported in 2003 that 91% of them intended to perform ERCP, even though only one-third had met ERCP volume thresholds for independent ERCP practice during fellowship training[1]. This disparity between clinical practice and professional guidelines continues to some extent even today, despite criticism of“l(fā)ow-volume” operators and endorsement of quality metrics, including highly successful biliary cannulation rates and low ERCP complication rates[3,31,32]. For example, a survey conducted in 2015 showed that 40% of graduating third year GI fellows believed that they would be able to perform ERCP independently upon graduation, even though only 19% of them had performed ≥ 200 ERCPs[26].

Competency

ERCP competency is defined as thoroughly understanding the cognitive aspects of ERCP, and reliably achieving its technical goals[33]. Patient outcome, patient satisfaction, and ERCP complication profile are also important. Criteria for competency, however, still remain controversial during the present era of numerous advanced GI fellowships (Table 3). One perspective suggested that biliary cannulation rate is a better parameter to assess competency than absolute ERCP numbers[34]. ERCP practitioners and trainees should incorporate best practice guidelines and prevention strategies to minimize complications, especially to prevent post-ERCP pancreatitis[35,36]. Overestimating ERCP skills or embellishing credentials can have dire clinical consequences[2].

Competency in ERCP was initially determined by numbers performed during GI fellowship training. An early study recommended an extremely low threshold of 35 ERCPs to achieve competency[37]. A prospective six-year study suggested a minimal threshold of 100 ERCPs to achieve competency, with a ＞ 85% biliary cannulation rate[38]. An important prospective study set 180-200 ERCPs as the threshold for competency, including 120 gallstone extractions, and 60 stent deployments[39]. An anecdotal Spanish study similarly recommended 200 ERCPs as the threshold for competency for surgeons[40], as was also recommended for gastroenterologists by the ASGE Standards of Practice Committee[41]. A systematic review, published in 2015,reported that in five studies, the minimum threshold for competency, as determined by very high rate of successful selective, duct cannulation, ranged from 79 to 300 ERCPs[42]. Cotton[26]published an editorial applauding these findings, and reiterating that too many low-volume operators were performing ERCP.

Recent published recommendations have become stricter. The Mayo Clinic study[43]recommended ＞ 350 ERCPs performed on a native papilla as a threshold for competency. Other studies included ERCPs on patients with prior sphincterotomy that renders biliary cannulation much easier. Recent studies suggest a ≥ 90% selective cannulation rate is an appropriate metric for a native ampulla[44], but a “competent”ERCP operator should attain a ≥ 95% rate in a papilla status post sphincterotomy or with precut maneuvers[43].

Assessment of ERCP competency based solely on numbers is flawed because of wide variability in: training programs, individual experiences within given training programs, exposure to ERCP during standard three-year GI fellowships, innate endoscopic ability of individual trainees, and difficulty in translating training results during GI fellowship into clinical practice[45]. For example, individual GI fellow experience at a given ERCP may vary from passive observation, attempting only one bile duct cannulation, performing the diagnostic ERCP, or performing the entire diagnostic and therapeutic ERCP. Also, individual learning curves for ERCP are nonlinear. Relative difficulty of ERCP procedures can be graded according to patient characteristics (e.g., stable patient vs acutely septic patient from ascending cholangitis), biliary anatomy (e.g., status post Billroth II vs native anatomy),procedural indication (e.g., obstructive jaundice vs recurrent idiopathic pancreatitis),and procedure intervention (e.g., solely diagnostic vs sphincterotomy and stone extraction for acute cholangitis). A reported grading system is useful to compare data on individual trainees or from different studies on ERCP competency[46](Table 4).

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

A recent trend is to emphasize learning curves rather than mere numbers. A Dutch study showed widely variable individual rates of acquisition of cognitive ability and technical skills, with a steeper learning curve for selective cannulation than for other technical skills, such as stent deployment[47]. A sophisticated multi-center American study of ＞ 1000 advanced endoscopy trainees reported a wide range of individual acquisition of cognitive ability and technical skills, which was only mildly-tomoderately correlated with ERCP volume[48]. Another large American study found that only 60% of advanced endoscopy trainees attained technical ERCP competence,even though all trainees achieved cognitive competency[49]. This study demonstrated the feasibility of a central database to determine individual learning curves for ERCP.The authors called their database tool TEESAT, an acronym for The EUS and ERCP Skills Assessment Tool. The 2017 ASGE Practice Guidelines[50]recommended that ≥200 ERCP's should be performed before competency is assessed, and that this minimum threshold should include ＞ 80 sphincterotomies, and ＞ 60 biliary stent deployments. A national board examination may be required in the future to assess cognitive ERCP skills.

Training

Advanced endoscopy fellowship training will eventually become the predominant route for ERCP practice. Paradigm shifts regarding advanced endoscopy training during the last two decades include: (1) Not mandating ERCP training during standard GI fellowships; (2) Exponential increase in number of advanced endoscopic fellowship training programs[51]; and (3) Recent transition from an “apprenticeship” to“milestones” model for medical education[30,31,52]. In the apprenticeship model, trainees are evaluated in relation to their peers at the same year of fellowship training. In the milestone model, trainees are evaluated by reaching appropriate interim milestones until they are evaluated for the ultimate milestone at graduation of competence for“independent practice”. The ASGE permits trainees to designate preference for training in EUS, ERCP or both, but applicants are generally more interested in ERCP,which is a more highly valued and marketable skill.

Table 4 Grading System for endoscopic-retrograde-cholangiopancreatography difficulty

Under the milestones paradigm, most advanced GI fellows achieved cognitive and technical goals, and were judged ready for independent practice[53], but the rate of skill acquisition was highly variable[42,45,48,49]. Number of ERCPs is deemed relevant only as a threshold to initiate formal assessment of achieving milestones for ERCP skills[45].

Various endoscopic simulators, including mechanical devices, virtual (computergenerated) models, organ explants, and live animals can help teach and train GI fellows in ERCP[51]. An inexpensive, simple, fabricated device boosted trainee confidence in performing actual ERCPs[54], while an elaborate, expensive European mechanical simulator was also helpful[55]. Computer simulators can improve ERCP skills[56]. Trainees can practice cannulation, sphincterotomy, and stent deployment using neo-papillae and neo-bile duct fashioned from chicken heart and trachea,respectively[57]. Simulators are useful adjuncts to formal training, but cannot replace actual clinical experience. Experienced ERCP operators can further improve their hands-on skills with workshops, such as those offered by the ASGE, especially for training in new and emerging technologies[58,59].

Credentialing

Credentialing is potentially contentious. A gastroenterologist without ERCP privileges is barred from performing ERCP. One-time denial is potentially tantamount to lifelong denial of this privilege because ERCP skills generally atrophy over time with disuse. Denial may decrease professional reputation because ERCP is perceived as a prestigious endoscopic procedure, and may decrease referrals for standard GI endoscopies because the gastroenterologist may be perceived as incapable of performing complex endoscopies.

Credential committee members have legitimate concerns about patient safety and potential malpractice litigation if applicants with borderline credentials are granted ERCP privileges, but the committee members could theoretically be biased against granting ERCP privileges to newly graduating GI attendings to stifle competition.However, institutional manpower needs and economic incentives may trump such concerns because patients with pancreatico-biliary diseases could be rerouted or transferred by ambulance to other hospitals if a given hospital has too few GI attendings with ERCP privileges.

A recent survey demonstrated that 21% of United States hospitals lack formal guidelines for initial credentialing for ERCP privileges, 59% of them lack formal guidelines for renewal of such privileges, 67% of them do not collect data on sphincterotomy rate or volume, and 85% of them do not collect data on rates of successful biliary cannulation[60]. After performing this survey, Cotton et al[60]reiterated his plea for adherence to credentialing guidelines, and establishing standardized national certification for ERCP. He recommended different criteria for initial credentialing for ERCP after completing GI fellowship, credentialing after one year of GI practice, and subsequent credentialing for renewal of ERCP privileges.Clinical studies suggest that 40 to 50 ERCP with sphincterotomies annually is a reasonable number to maintain ERCP proficiency, as evidenced by such high volume operators having a lower risk of ERCP complications than low volume operators[61,62].The accompanying editorial endorsed Cotton's proposal, called the current credentialing process “alarming”, and urged credential committees to analyze more data on ERCP outcomes and hospital course[63]. Publications on ERCP competency including original articles, position papers, recommended guidelines, and editorials are listed in Table 5. Most authorities believe that endoscopists performing high volumes of ERCPs generally provide higher quality ERCPs and improve patient outcome compared to endoscopists performing low volumes of ERCPs[31,64-66]. Lowvolume operators derive less personal satisfaction from performing ERCP, possibly because of greater stress, and may be viewed less favorably by endoscopy personnel[65].

GI endoscopists who perform ERCPs at several hospitals pose another problem.How can endoscopists who rarely perform ERCPs at a given hospital be evaluated for re-credentialing based on the limited data available at this given hospital? Who manages patient complications after ERCP when the performing gastroenterologist is away at another hospital? Should all endoscopists with ERCP privileges be compelled to participate in on-call rotations for emergency ERCPs that must be performed at night or on weekends, and should all of them be compelled to participate in a rotation to perform ERCPs on patients without medical insurance? At Beaumont Hospital at Royal Oak, renewal of privileges has been linked to enrolling in an on-call rotation for emergency ERCPs and in a rotation for uninsured patients requiring ERCPs.

Manpower needs

Few studies analyze United States manpower needs for ERCP. The approximately 350000-500000 ERCPs performed annually in the United States[3,5]are mostly performed by endoscopists without advanced endoscopy training, and this predominance will likely persist for years to come. In Cotton's survey published in 2017[60,63], only one-quarter of surveyed ERCP operators in the United States had advanced ERCP training, and these practitioners typically practiced in academic urban or suburban hospitals. Rigorous vetting of applicants for ERCP privileges could limit the number of operators. Rigorous vetting should work well in densely populated urban areas with high concentrations of ERCP operators, but may be problematic in rural and inner-city hospitals that are likely underserved in number of ERCP operators. This phenomenon may explain the reluctance of some hospitals to rigorously follow professional ERCP guidelines. Transferring patients from inner city or rural hospitals to academic medical centers for emergency ERCPs, for indications such as acute cholangitis or bile leaks, is problematic. Gastroenterologists at lowvolume ERCP centers may solicit medical advice by telephone or video communications from ERCP experts at high-volume centers[67]. To adapt to local shortages of gastroenterologists performing ERCPs, surgeons could increase their rate of performing intraoperative cholangiography and could potentially perform ERCP themselves[68,69], while interventional radiologists could perform transhepatic cholangiography as a substitute for ERCP.

The duties of the individual GI fellow applying for ERCP privileges, of the supervisory attending, and of the credentialing committee at which the GI fellow is applying for ERCP privileges upon completion of the fellowship are summarized in Table 5. Upon graduation of a GI fellow, training programs should issue a nationally standardized certificate regarding ERCPs that provides quantitative data on numbers of ERCPs and percentages of successful therapeutic interventions (proposed ERCP report card illustrated in Table 6). Credentialing should grant preference to trainees who performed an extra year of GI fellowship mostly devoted to ERCP training.

This work has proposed that national criteria be mandatory rather than recommended. One reasonable method of enforcement is for chairs of credentialing committees to certify that the physician was granted ERCP privileges in accord with the national criteria. This certification may, however, prove to be an inadequate remedy. An ultimate solution is to establish a Board for ERCP certification similar to the American Board of Internal Medicine that would remove politically difficult decisions on privileging from hospital committees. Cappell has personal experiences of enduring political pressures during 6 cases of applicants denied ERCP privileges and in 1 case of an applicant approved ERCP privileges despite borderline credentials(personal unpublished data, Cappell). Requiring certification by a national board would dissociate deliberations from local political considerations and would avoid flouting of the numerous recommended guidelines, position papers, and recommendations promulgated during the past 30 years.

Table 5 Determining competency for endoscopic-retrograde-cholangiopancreatography

The advent of MRCP and EUS has improved the landscape so that ERCP is now rarely indicated solely for diagnosis. Current diagnostic ERCP indications are restricted to subtle primary sclerosing cholangitis, chronic pancreatitis, and indeterminate biliary strictures[70]. MRCP is limited by contraindications from implanted metal devices, high imaging cost, technical expertise required for performance and interpretation, and occasionally claustrophobia. EUS is often performed by the same operator who would perform the contemplated ERCP. Acquisition of endoscopic skills in both ERCP and EUS is therefore highly desirable during advanced GI fellowship training. A“negative” MRCP or EUS can obviate the need for ERCP[71]in about 70% and 50% of cases, respectively[72]. Such avoidance of ERCP is desirable because patients without evident malignancy or choledocholithiasis may be more susceptible to ERCP-induced pancreatitis[73].

CONCLUSION

ERCP training and credentialing has become a growing concern during the last thirty years. ERCP differs from most other endoscopic procedures in its predominantly therapeutic intent, necessity for typical performance in hospitals, steep learning curve,and penchant for occasionally causing severe complications. ERCP training has undergone several paradigms shifts during the past 50 years including: (1) Change to not requiring ERCP training during standard GI fellowship; (2) Recommendation for training in advanced endoscopy fellowships to obtain privileges in ERCP; (3) Recent exponential growth in number of advanced endoscopy fellowships; and (4) recent shift in ERCP training from an apprenticeship to milestone model, which emphasizes progressive milestones in competence until ultimately achieving independent practice at graduation. Advanced fellows and advanced fellowships have been increasingly

MRCP and EUS

scrutinized regarding ERCP skills, as reflected by at least 12 publications on this subject during the past 5 years (Table 1), including analysis of trainee learning curves and criteria for ultimate competency. ERCP authorities frequently call to improve standardization of ERCP competence and performance, including quality metrics,such as high rates of successful biliary cannulation and low rates of procedural complications. The advanced endoscopy-trained pool remains relatively limited, and most ERCP operators have been trained during a standard GI fellowship or by other means. Hospital credentialing committees have to balance patient safety and risk of medical malpractice litigation versus real-world needs for available ERCP operators and desire for increased hospital revenue from treating patients requiring ERCPs.Credentialing in ERCP by any route other than advanced endoscopy training is expected to become increasingly difficult.

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

ERCP: Endoscopic retrograde cholangiopancreatography.

All hospitals need to establish or adopt written criteria for ERCP privileges that are standardized according to national guidelines. Hospitals should be granted a transition period to implement these criteria. Criteria should include minimum number of ERCPs required to apply for privileges and minimum annual volume to maintain privileges. These criteria may specify numbers required for specialized ERCP procedures, including sphincterotomy, stricture dilatation, stent deployment,stone extractions, and per-oral cholangiopancreatoscopy. Hospitals will have to develop criteria for minimally acceptable rates of successful biliary cannulation,sphincterotomy, and gallstone extraction. Hospitals may also have to determine maximal acceptable rates of major post-ERCP complications, especially for ERCPinduced pancreatitis, clinically significant post-sphincterotomy bleeding, and bile leaks. These criteria would benefit hospitals by establishing firm criteria for granting versus denying ERCP privileges, protect applying physicians from being denied ERCP privileges for competitive rather than professional reasons, and protect patients from inadequately trained ERCP operators. Institutional GI morbidity and mortality committees should review all mortality from major ERCP complications including ERCP-induced pancreatitis, post-sphincterotomy bleeding, bile leaks, or duodenal perforations.

Implementing and following stricter ERCP regulations would likely introduce new direct costs from the work required to closely monitor ERCP practitioners, and indirect costs from reduction in the number of ERCP operators. Public health administrators need to realize that increased regulation is costly and budget these inherent costs to benefit patient care. Criteria for ERCP competency still remain controversial in 2019 and are sometimes flouted by hospitals despite the numerous studies, position papers, editorials, and recommended guidelines for ERCP competency. Mandatory criteria monitored by a national board, similar to the National Board of Medical Examiners or American Board of Internal Medicine, would provide nationally uniform criteria, which would be divorced from local political considerations of individual practitioners, their GI groups, competing GI groups, and given hospital, and would avoid widespread flouting of recommended guidelines.