Does trainee participation impact critical outcomes in ERCP?

Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic modality for complex pancreaticobiliary disorders. Overall, there has been an increase in the number of therapeutic ERCPs performed and a decline in diagnostic ERCPs, at least in Western populations. This shift has resulted in increased complexity of ERCP, raising the requisite expertise and the risks for adverse events (pancreatitis, perforation, hemorrhage, infection, and failed procedures).

There is widespread acknowledgement that ERCP is operator dependent and a technically challenging procedure that requires unique technical, cognitive, and integrative skills [1]. The number of advanced endoscopy training programs has increased significantly in the past two decades in the United States and Europe [2]. Training in ERCP in the United States typically involves enrollment in a 1-year advanced endoscopy fellowship program. Using a validated skills assessment tool (TEESAT – The EUS and ERCP Skills Assessment Tool), our research has shown that: (i) trainees learn at variable rates, (ii) the number of procedures completed is a suboptimal marker for competency, (iii) overall success in ERCP is not only dependent on cannulation rates but also other technical and cognitive aspects, and (iv) although competence cannot be confirmed for all trainees at the end of training, most meet quality indicator thresholds for ERCP at the end of the first year of independent practice [1] [3]. This essentially validates the shift away from absolute number of procedures performed as a measure of competency to performance metrics with well-defined and validated thresholds of performance [2]. However, few studies have evaluated the relationship between trainee involvement and clinical outcomes in ERCP.

“The current study by Voiosu et al. has laid the foundation for future research exploring the potential for a tailored and milestone-based approach to training.”

In this issue of Endoscopy, Voiosu et al. have addressed this critical knowledge gap in the field of ERCP training [4]. The primary aim of their prospective, multicenter, observational study was to compare the technical success and adverse event rates between ERCPs performed with or without the participation of trainees. To improve the generalizability of results, the investigators included both high and low volume centers using a threshold of 1000 ERCPs/year across Southeastern Europe. Trainee involvement was defined as endoscopists with < 200 ERCPs. Similarly to previous studies [5], technical success was defined as the ability to achieve the planned diagnostic and/or therapeutic procedure, and the presence and severity of adverse events were defined using standardized criteria based on a 30-day follow-up using patient chart reviews or telephone interviews [6]. The degree of trainee involvement was documented for all procedures using a four-point scale ranging from failed cannulation to completion of the procedure without hands-on assistance from the trainer. Trainees were involved in 45 % of all procedures and adverse events occurred in 15 % of all procedures. There was no difference in technical failure (7.6 % vs. 6.3 %) or adverse event rates (14.7 % vs. 14.6 %) between procedures with and without trainee involvement, respectively. Trainee participation was not an independent predictor for any procedure-related adverse event (odds ratio [OR] 1.18, 95 % confidence interval [CI] 0.72 – 1.93) or procedure failure (OR 1.23, 95 %CI 0.36 – 4.17).

While the results are reassuring on the surface for trainers, trainees, and our patients, they should be put into context of a few important limitations. Inherent differences in the management of patients at different sites and the lack of standardized assessment of adverse events raises the concern for under-reporting of adverse events. There is also the potential for assessment bias given the fact that adjudication of adverse events was not made by individuals blinded to the involvement of trainees in the procedure. In addition, there is a risk of selection bias with regard to the cases that trainees were involved in. Although there was no difference between the two groups with regard to the number of native papilla cases (trainee group 565 vs. control group 754, P = 0.07), trainees were less likely to be involved in grade 2 and grade 3 ERCPs compared with the control group (17.7 % vs. 25.0 %, P = 0.002). This resulted in a higher rate of moderate-to-severe adverse events in the control group (6.2 % vs. 3.4 %, P = 0.01). While it may be safe to perform grade 1 ERCPs with trainees, this study does not answer a fundamental question: Does trainee participation increase the risk of negative outcomes in patients deemed to be at the highest risk of adverse events and technical failure? This study was not powered to assess the association between trainee involvement and increase in specific adverse events such as post-ERCP pancreatitis. Finally, this study does not assess the relationship between trainee skills as assessed by a validated skills assessment tool and relevant ERCP outcomes.

Moving forward, there is a need to validate the relationship between trainee involvement and clinical outcomes in ERCP in a large prospective multicenter trial that standardizes assessment of adverse events in a blinded fashion. Addressing this priority research question, along with the assessment of trainee skills using TEESAT and its association with outcomes in high risk ERCP cases, are the primary aims of an ancillary study to a large ongoing multicenter study (clinicaltrials.gov NCT02476279). The current study by Voiosu et al. has laid the foundation for future research exploring the potential for a tailored and milestone-based approach to training. This may involve trainee involvement in low risk cases during the early phases of training to high risk cases when certain thresholds of performance are met. There is a critical need for the development of prediction models to identify ERCPs associated with the highest risk of adverse events and technical failure. What is ready for primetime is the systematic assessment of competence in ERCP among trainees using a standardized and validated tool such as TEESAT that allows identification of targeted skill deficiencies and tailored individualized remediation. This will ensure that training programs and trainers achieve the collective goal of graduating trainees who can safely and effectively perform this high risk endoscopic procedure in independent practice.

• References

• 1 Wani S, Keswani RN, Han S. et al. Competence in endoscopic ultrasound and endoscopic retrograde cholangiopancreatography, from training through independent practice. Gastroenterology 2018; 155: 1483-1494.e7
• 2 Wani S, Keswani RN, Petersen B. et al. Training in EUS and ERCP: standardizing methods to assess competence. Gastrointest Endosc 2018; 87: 1371-1382
• 3 Wani S, Keswani R, Hall M. et al. A prospective multicenter study evaluating learning curves and competence in endoscopic ultrasound and endoscopic retrograde cholangiopancreatography among advanced endoscopy trainees: the Rapid Assessment of Trainee Endoscopy Skills study. Clin Gastroenterol Hepatol 2017; 15: 1758-1767.e11
• 4 Voiosu T, Boskoski I, Voiosu A. et al. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy 2020; 52: 115-122
• 5 Keswani RN, Qumseya BJ, O’Dwyer LC. et al. Association between endoscopist and center endoscopic retrograde cholangiopancreatography volume with procedure success and adverse outcomes: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2017; 15: 1866-1875.e3
• 6 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454