ERCPトレーニングにおけるハンズオン支援とハンズオフ支援のトレーニング効果の比較：ランダム化比較試験

Endoscopic retrograde cholangiopancreatography (ERCP) is intricate and necessitates comprehensive training. The conventional hands-on approach in ERCP training may not be essential for improving trainee performance or ensuring procedure safety. We hypothesized that hands-off assistance would be non-inferior to hands-on assistance in terms of cannulation success by trainees during ERCP training.

A total of 770 patients with native papilla were randomized to either the hands-off (intervention, n = 389) group, where trainers offered verbal guidance via teleguidance using real-time endoscopic and fluoroscopic feeds, or the hands-on (control, n = 381) group, where trainers provided on-site verbal and restrictive hands-on assistance. Eight trainees with preliminary cannulation experience were involved. The primary outcome was the successful cannulation rate within 10 min by trainees. ITT analysis was performed and non-inferiority was established if the lower bound of the 95% confidence interval for the difference in success rates exceeded -10%.

Cannulation success rates were nearly identical (222/389, 57.1% vs. 218/381, 57.2%; absolute difference - 0.1%, 95%CI -7.1% to 6.8%; noninferiority P = .002). There was no difference in total cannulation time and attempts between the two groups. Verbal instruction and performance scores were comparable between the two groups. The incidence of adverse events was 8.2% (32/389) vs. 9.2% (35/381) (P = .73), including pancreatitis (5.7% vs. 6.8%), bleeding (1.3% vs. 0), and cholangitis (2.1% vs. 2.6%) (all P > .05). Trainers in the hands-off group received minimal radiation exposure.

The hands-off training showed non-inferior effectiveness and safety to the hands-on training. The alternative method can be integrated into the traditional ERCP training. Key messages What is already known on this topic: Conventional endoscopic retrograde cholangiopancreatography (ERCP) training relies heavily on direct, hands-on supervision by experienced endoscopists to guide trainees during procedures. While teleguidance (remote supervision using real-time imaging) has been proposed as a potential alternative, robust evidence comparing its effectiveness and safety to traditional hands-on assistance has been lacking. What this study adds: This randomized trial demonstrates that hands-off assistance using teleguidance is non-inferior to hands-on assistance for trainee cannulation success rates (57.2% vs. 57.1%) and overall patient safety (complication rates 8.2% vs. 9.2%). It also significantly reduces radiation exposure for trainers without increasing trainees' fluoroscopy time or compromising procedural outcomes. How this study might affect research, practice, or policy: The findings support integrating hands-off training via teleguidance into ERCP curricula, offering a viable alternative that maintains trainee performance while reducing trainer radiation risk. This approach could expand training capacity, particularly in settings with limited expert availability, and prompts further research into optimizing remote supervision for complex cases and long-term competency assessment.