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Effect of hands-on versus hands-off assistance on trainee performance in ERCP training: a randomized controlled study
Xu Wang1, Lijun Lou1, Chenxi Kang1
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers and National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, 127 Changle West Road, Xincheng District, Xi'an, Shaanxi 710032, China.
Hands-off endoscopic retrograde cholangiopancreatography (ERCP) training using teleguidance is as effective and safe as traditional hands-on training. This method reduces trainer radiation exposure without impacting trainee performance or patient outcomes.
Area of Science:
- Gastroenterology
- Medical Education
- Surgical Simulation
Background:
- Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure requiring extensive training.
- Traditional hands-on training may not be essential for trainee performance or patient safety.
- The effectiveness and safety of hands-off versus hands-on ERCP training lacked robust evidence.
Purpose of the Study:
- To hypothesize that hands-off assistance is non-inferior to hands-on assistance in ERCP training.
- To compare the cannulation success rates and safety of hands-off versus hands-on ERCP training for trainees.
- To evaluate the impact on trainer radiation exposure and trainee procedural outcomes.
Main Methods:
- A randomized trial involving 770 patients with native papilla.
- Trainees were randomized to either hands-off (teleguidance) or hands-on assistance groups.
- The primary outcome was successful cannulation within 10 minutes; non-inferiority was assessed using ITT analysis.
Main Results:
- Cannulation success rates were nearly identical: 57.1% (hands-off) vs. 57.2% (hands-on).
- No significant differences were observed in cannulation time, attempts, or performance scores.
- Adverse event rates were comparable (8.2% vs. 9.2%), with minimal radiation exposure for trainers in the hands-off group.
Conclusions:
- Hands-off ERCP training via teleguidance is non-inferior in effectiveness and safety to hands-on training.
- This alternative method can be integrated into ERCP curricula, reducing trainer radiation risk.
- Findings support expanding training capacity and further research into optimizing remote supervision techniques.
