Fast-tracking ERCP learning with the Boškoski-Costamagna Trainer: results of a multicenter randomized clinical trial

Background Achieving competence in endoscopic retrograde cholangiopancreatography (ERCP) requires extensive training. Recognizing the potential of simulator-based education for safe and effective skill development, we aimed to assess whether initial training with the Boškoski-Costamagna ERCP Trainer (BCT) is beneficial compared with conventional training alone (i. e. predictive validity). Methods A prospective multicenter randomized trial involving 16 novice ERCP trainees, randomly assigned to intervention or control groups, was performed. Both underwent hands-on training, with the intervention group receiving additional simulation training during the first 3 months. Each trainee was required to complete a minimum of 60 ERCPs in up to 1 year. The TEESAT score evaluated rates of global overall competence (primary outcome), biliary cannulation, and adverse events (AEs; secondary outcomes). Mixed-effect logistic regression models assessed differences in between-group ERCP procedure competence and success. Learning curves were generated cumulatively over the training period. Results 1106 ERCPs (562 simulator group; 544 control group) were included. Although no statistically significant difference in global overall competence was observed between the groups, possibly owing to data heterogeneity, simulation training demonstrated higher success for native biliary cannulation (52% vs. 42%; P < 0.001) and faster median (interquartile range) biliary cannulation times (3 [6] vs. 5 [8] minutes; P < 0.001). The simulator group also showed faster improvements in overall performance, native biliary cannulation, and sphincterotomy. No statistical difference was found in overall AEs between the groups. Conclusion Early simulation training with the BCT improved technical competence in native biliary cannulation and accelerated overall ERCP learning. This approach has the potential to enhance ERCP training programs.