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.