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ERCP (Ensuring Really Competent Practice): enough words—action please!

      The American Society for Gastrointestinal Endoscopy (ASGE) and other relevant professional organizations are prominent advocates for the quality of endoscopy. Quality is clearly important for all of our procedures, but ERCP is somewhat special, not least because is it at least 20 times more dangerous than the other standard procedures. There have been a string of well-meaning publications over the years, including my own, and the broken record continues to spin. In this issue of the journal, Shahidi and colleagues
      • Shahidi N.
      • Ou G.
      • Telford J.
      • et al.
      When trainees reach competency in performing ERCP: a systematic review.
      review the literature on the numbers of hands-on cases trainees may need to achieve competence in ERCP, as they did earlier for colonoscopy. They were unable to reach a firm conclusion, mainly because the studies used different methods, but they concluded that “threshold numbers have risen well above North American training guidelines.” Those guidelines themselves are somewhat vague, often suggesting a success rate (of 85%-90%) for cannulation, and leaning on the seminal paper (now 20 years old) by Jowell and colleagues
      • Jowell P.S.
      • Baillie J.
      • Branch M.S.
      • et al.
      Quantitative assessment of procedural competence: a prospective study of training in endoscopic retrograde cholangiopancreatography.
      that threw 180 to 200 cases into the mix.
      Can we define and measure competence better? It is not a question of overall numbers, although we know that more is better.
      • Guda N.M.
      • Freeman M.L.
      Are you safe for your patients – how many ERCPS should you be doing?.
      • Coté G.A.
      • Imler T.D.
      • Xu H.
      • et al.
      Lower provider volume is associated with higher failure rates for endoscopic retrograde cholangiopancreatography.
      It is still not clear what exactly should be measured and how, and no one has defined how much a trainee must be involved to be able to count it as a case.
      Deep biliary cannulation is often proposed as a key metric and is certainly important, but it is a surrogate, and it would be better to focus on completing the therapy. Which techniques must be taught and mastered? Although it would be nice if all ERCPists had all of the many skills, that is clearly unrealistic. We know that the vast majority of ERCPs in the community are done for solid biliary indications (ie, stone extraction and biliary stent placement for low lesions and leaks). We should concentrate on those procedures in basic training. Happily, those metrics are among the ones proposed in the January 2015 issue of this journal, which is a treasure trove of information about quality in training and practice in ERCP.
      • Adler D.G.
      • Lieb J.G.
      • Cohen J.
      • et al.
      Quality indicators for ERCP.
      Up for discussion is the question whether this basic level of training should include placing prophylactic pancreatic stents, and precutting. In passing, I suggest that some training in these techniques (especially precutting because it is an uncommon procedure in the hands of experts in training centers) can and should be done on simple models, of which several are now available.
      In the past, competence has been assessed in cohorts of 20 cases in a smorgasbord of ERCP techniques. Why not require that trainees complete a certain number of each (say 20) of these standard biliary procedures, unaided? That would be easier for fellows to document and trainers to confirm.
      There are nuances to the word “unaided.” It usually means no hands-on by the trainer, but the skills of the assisting nurse, radiology technician, and anesthesiologist also affect the likelihood of success. ERCPists who have traveled to other centers and countries to do demonstrations are fully aware of these aspects. The demonstrations also greatly affect the results for trainees newly released from the mother ship. It is one thing to succeed in familiar surroundings with known staff and equipment and a mentor in attendance offering advice, but quite another to solo in a hospital that rarely hosts an ERCP. It follows that the center volume is also important, as has been shown repeatedly for surgical procedures.
      Our goal is to help patients. Has anyone asked what they want and deserve? Having hung up my scope in my advanced maturity, I am beginning to think more like a potential patient than a practitioner. What would I hope for if taken sick with cholangitis on a remote golf course in the United States, or indeed anywhere? Obviously, I would want access to someone who could unblock my bile duct (by removing my stone or placing/replacing a stent) reasonably safely, and who is not too far away.
      How could I tell whether the nice local on-call gastroenterologist fits the bill? Board certification doesn’t help, and I doubt whether he or she will be able to provide me with useful data. Does the hospital have the necessary facilities, equipment, and staff? Does it give privileges only to people with proven competence? Several reports and my extensive experience as an expert witness in ERCP lawsuits show that these essentials are not always in place.
      A survey of third-year fellows in 2003 concluded that 64% of them did not achieve procedural competence; nevertheless, 91% expected to perform unsupervised ERCP in practice.
      • Kowalski T.
      • Kanchana T.
      • Pungpapong S.
      Perceptions of gastroenterology fellows regarding ERCP competency and training.
      It would be nice to think that the situation would be better 12 years later, but another recent survey showed that 40% of third-year fellows believed that they will able to perform ERCP independently, even though 66% will be involved with fewer than 100 ERCPs during training, and only 19% with more than 200.
      • Wani S.
      • Keswani R.N.
      • Elta G.E.
      • et al.
      Perceptions of training among program directors and trainees in complex endoscopic procedures (CEPs): a nationwide survey of US ACGME accredited gastroenterology training programs.
      One of our recent fellows, when entering practice, was asked to join the ERCP roster, having done precisely 7 procedures in training. And, to add insult to injury, we have seen the guidelines for recredentialing from a well-respected large community hospital that sets the bar at 1 ERCP in the previous year.
      What can be done to resolve this unsatisfactory situation? The simple (simplistic) answer would be to appoint an ERCP tsar (probably myself) and to assemble and empower an ERCP Quality Task Force. This would embrace all interested stakeholders, including gastroenterologists, surgeons, trainers, quality assurance people, patient advocates, payers, and even lawyers.
      We would look first at the workforce needs. That shouldn’t be too difficult because we know that close to 1:1000 of the population undergo an ERCP each year.
      • Cotton P.B.
      Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW.
      Most of these are the standard biliary procedures that are needed at the community level, so that will be our initial focus. We would restrict the number of training places to ensure that those chosen have a good chance of achieving competence. When they do so, we would issue a certificate to reassure future practice partners and credentialing committees.
      We would need also to consider how many trainees would need extra training to do the advanced procedures in referral centers, and to teach them effectively. Many of the current fourth-year positions in the United States are constrained by the fact that most trainees enter them with little experience, and that some of their time is consumed with service work. We would construct integrated 4-year programs concentrating on advanced endoscopy in the third and fourth years, hoping to get a small number of talented individuals up to speed in ERCP, EUS, mucosal resections, and other advanced techniques. Their competence in ERCP would be tested on their ability to complete (unaided) a specified number of the complex procedures, such as minor papilla cannulation, hilar stenting, and pseudocyst drainage. Those reaching those goals would get an advanced certificate.
      To make sure that our graduates perform well away from the mother ship, we would continue to monitor their performance in practice (especially in the first year or two). That would require a relatively painless process for collecting data and an analysis system that allows comparison with peers (ie, benchmarking).
      I initiated the voluntary ERCP Quality Network 8 years ago, and eventually I collected and compared data from more than 150 ERCPists, mainly in the United States.
      • Cotton P.B.
      • Romagnuolo J.
      • Faigel D.O.
      • et al.
      The ERCP quality network: a pilot study of benchmarking practice and performance.
      This was closed when the ASGE/American College of Gastroenterology GI Quality Improvement Consortium (GIQuIC) initiative started with similar goals.

      GIQuIC. Available at: www.giquic.gi.org. Accessed Jan 28, 2015.

      We can hope that it will soon add ERCP to its current successful modules in colonoscopy and upper endoscopy. The Holy Grail is seamless extraction and transmission of the key metrics from the electronic reporting systems. That would make it easy to use and very difficult to game. The GIQuIC system is currently voluntary. My Task Force will mandate its universal use, giving patients and providers (endoscopists, hospitals, and payers) the data they need to make meaningful decisions. Hospitals that reach and document our standards will be certified as “ERCP Centers of Excellence.”
      The chance of initiating such imperatives in the United States anytime soon are clearly remote, but we can perhaps learn from what has been done in more structured societies. The British gastroenterology community recognized that it had serious endoscopy quality problems about 10 years ago. The government did indeed appoint an endoscopy tsar (Roland Valori) and a multidisciplinary committee (Joint Advisory Group, JAG), and the results have been extremely impressive across the discipline.

      British Society of Gastroenterology. Available at: www.bsg.org.uk/clinical/news/ercp-–-the-way-forward-a-standards-framework.html. Accessed Jan 28, 2015.

      As far as ERCP is concerned, training positions are now strictly limited, and electronic logs are available; practice is restricted to those doing more than 75 per year (intended to rise to 100) and in centers doing at least 150 per year (rising to 200). They also addressed the “mother ship” issue by stating that newly launched ERCPists should be mentored for their first 100 cases in practice.
      Lest we think that these standards can be achieved only in socialized societies, we can learn also from progress in Australia, which, like the United States, is divided into states, which do not always agree. Their Conjoint Committee includes all of the stakeholders and makes the rules. The web site contains some high hurdles. “Trainees are required to have previous recognition of training in upper gastrointestinal endoscopy. Trainees must perform a total of 200 unassisted ERCP examinations in patients with intact papillary sphincters. Procedures performed must include a minimum of 80 supervised, independently performed, sphincterotomies in patients with intact papillary sphincters and a minimum of 60 stents.”

      The Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy. Available at: www.conjoint.org.au. Accessed Jan 29, 2015.

      What can be done in the United States, where it appears that many graduates enter ERCP practice with marginal skills, and then do fewer than 25 cases per year in hospitals doing fewer than 50?
      • Guda N.M.
      • Freeman M.L.
      Are you safe for your patients – how many ERCPS should you be doing?.
      • Coté G.A.
      • Imler T.D.
      • Xu H.
      • et al.
      Lower provider volume is associated with higher failure rates for endoscopic retrograde cholangiopancreatography.
      I published a 9-point action plan 4 years ago in this journal, with little impact, but it might be worth revisiting.
      • Cotton P.B.
      Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW.
      The ASGE has moral authority, and some influence, but no real power. The key drivers will be the 3 Ps: Privilegers (hospitals), Payers, and Patients.
      As reimbursement systems change, hospitals will quickly realize (with bundling) that there are financial penalties (rather than actual benefits, as now) for failed procedures and readmissions, and indeed for legal redress when they give privileges to incompetent practitioners. They would be well advised to install GIQuIC for ERCP as soon as it is available, so as to be able to track outcomes and enhance quality. Those practitioners who fall below the bar will lose their credentials, stop performing ERCP, or seek mentoring and remediation.
      One reason, apparently, why many practitioners continue to practice ERCP at low volumes is to provide emergency services without overburdening their colleagues in the group. Clearly, the answer is for practices to collaborate to provide a roster of skilled individuals. They would be forced to do so if hospitals were less generous with privileges. The ASGE Endoscopy Unit Recognition program recently added some verbiage about collecting ERCP quality data, but of course that program is voluntary, and it mainly serves to confirm to the contributing centers that they are as good as they already know that they are. We have no way to reach the practitioners and hospitals at the other end of the quality spectrum. How do we influence those who endanger their patients and disgrace our profession by continuing to do ERCPs and sphincterotomies (and precuts) in patients with “pain only,” despite the strong condemnation by all authorities, not least the National Institutes of Health?
      • Cohen S.
      • Bacon B.R.
      • Berlin J.A.
      • et al.
      National Institutes of Health State-of-the-Science Conference Statement: ERCP for diagnosis and therapy, January 14-16, 2002.
      The Payers could have serious power if they compensated only those endoscopists with my new certificate, and only those hospitals designated as Centers of Excellence. Only very altruistic endoscopists would continue to interrupt their days to perform ERCP if no checks were forthcoming.
      Educating the public is the other key to having an impact on this situation. Patients are gradually waking up to the fact that ERCP is very different from the other procedures that they may have experienced, which should of course be made clear in the informed consent process. Is it always? One patient told me she was informed that “ERCP is just like the upper endoscopy we did last week, but we go a little further.” Another, when asking about the risks, was told, “The risks are less than those of your driving here today.” Perversely, the recent publicity about the risks of “super bug” infection may help. When asking whether the instruments have been well prepared (as they surely will), patients may pause to ask the same of the person offering to do the procedure. For years I have advocated being prepared to provide patients with the data (report cards) with which they can make informed choices.
      • Cotton P.B.
      How many times have you done this procedure, doctor?.
      ERCPists able to do so will eventually have a practice advantage (and sleep better).
      Let’s stop writing reviews and editorials and press for meaningful action in all of these aspects.

      Disclosure

      The author disclosed no financial relationships relevant to this publication.

      References

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        When trainees reach competency in performing ERCP: a systematic review.
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        Quantitative assessment of procedural competence: a prospective study of training in endoscopic retrograde cholangiopancreatography.
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        Are you safe for your patients – how many ERCPS should you be doing?.
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        Quality indicators for ERCP.
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        • Kanchana T.
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        Perceptions of gastroenterology fellows regarding ERCP competency and training.
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        • Keswani R.N.
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        Perceptions of training among program directors and trainees in complex endoscopic procedures (CEPs): a nationwide survey of US ACGME accredited gastroenterology training programs.
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        Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW.
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      1. GIQuIC. Available at: www.giquic.gi.org. Accessed Jan 28, 2015.

      2. British Society of Gastroenterology. Available at: www.bsg.org.uk/clinical/news/ercp-–-the-way-forward-a-standards-framework.html. Accessed Jan 28, 2015.

      3. The Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy. Available at: www.conjoint.org.au. Accessed Jan 29, 2015.

        • Cohen S.
        • Bacon B.R.
        • Berlin J.A.
        • et al.
        National Institutes of Health State-of-the-Science Conference Statement: ERCP for diagnosis and therapy, January 14-16, 2002.
        Gastrointest Endosc. 2002; 56: 803-809
        • Cotton P.B.
        How many times have you done this procedure, doctor?.
        Am J Gastroenterol. 2002; 97: 522-523

      Linked Article

      • When trainees reach competency in performing ERCP: a systematic review
        Gastrointestinal EndoscopyVol. 81Issue 6
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          ERCP is an advanced endoscopic procedure that is technically more challenging and carries a higher risk of adverse events compared with standard endoscopy. A discrepancy currently exists among guidelines regarding the number of ERCPs that a trainee needs to complete before procedural competency should be assessed. Our aim was to assess the learning curve for performing ERCP.
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