A simple clinical score to stratify the risk of procedure-related adverse events in ERCP procedures with trainee involvement.

BACKGROUND : Optimal training strategies in endoscopic retrograde cholangiopancreatography (ERCP) remain controversial despite the shift toward competence-based training models, with limited data available on patient safety during training. We aimed to assess whether pre-procedural clinical predictors could identify patients at low risk of developing procedure-related adverse-events (AEs) in a training environment. METHODS : We performed a prospective, multicenter, cohort study in five training centers. A data collection system documenting indication, clinical data, trainee performance (assessed using a validated competence assessment tool), technical outcomes, and AEs over a 30-day follow-up was utilized. We developed a clinical risk score (Trainee Involvement in ERCP Risk Score [TIERS]) for patients undergoing ERCP and compared the rate of AEs in a training environment between low-risk and high-risk groups. The association between trainee performance and AE rate was also evaluated. RESULTS : 1283 ERCPs (409 [31.9 %, 95 %CI 29.3 %-34.4 %] with trainee involvement) performed by 11 trainers and 10 trainees were analyzed. AEs were more frequent in the high-risk compared with the low-risk group: 26.7 % (95 %CI 20.5 %-34.7 %) vs. 17.1 % (95 %CI 12.8 %-22.2 %). TIERS demonstrated a high negative predictive value for AEs (82.9 %, 95 %CI 79.4 %-85.8 %) and was the only predictor of AEs on multivariable analysis (odds ratio 1.38, 95 %CI 1.09-1.75). Suboptimal trainee performance was associated with an increase in AE rates. CONCLUSION : Simple, clinical-based predictive tools could improve ERCP training by selecting the most appropriate cases for hands-on training, with the aim of increasing patient safety.

Informations de copyright

Thieme. All rights reserved.

Déclaration de conflit d'intérêts

I. Boskoski is a consultant for Cook Medical, Boston Scientific, and Apollo Endosurgery, a holder of a research grant from Apollo Endosurgery, and a Scientific Board Member for Endo Tools. S. Wani is a consultant for Castle Biosciences and Exact Sciences, and has received research funding from CDx Diagnostics, Lucid, and Ambu. T.A. Voiosu, A. Benguș, M. Bronswijk, I. Lyutakov, I. Klarin, B. Voiosu, P. Bălănescu, C. Diaconu, B. Busuioc, A.M. Voiosu, and R.B. Mateescu declare that they have no conflict of interest. The research was supported by NIH/NIDDK—U34-DK124174, U01DK129191.