Development and preliminary evaluation of a novel low-cost endoscopic retrograde cholangiopancreatography simulator with electrocautery training capability: a proof-of-concept study from India.

BACKGROUND/AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) requires extensive training, with around 350-400 supervised cases being required for proficiency. Existing simulators face costs, limited availability, and limited realism. Therefore, we developed and preliminarily evaluated a minimal ERCP training model that incorporated electrocautery capabilities. METHODS: A five-phase development process was employed, including needs assessment, iterative prototyping with material optimization, technical performance testing across 50 training sessions, comparative analysis against existing simulators, and preliminary expert evaluation by eight experienced endoscopists (mean ERCP experience: 12.3±4.2 years). The primary outcomes included verification of functional capability, cost analysis, durability assessment, and expert ratings on 5-point Likert scales for realism and educational value. RESULTS: The simulator successfully achieved biliary cannulation in 48/50 sessions (96.0%), supported needle knife precut training with functional electrocautery, and demonstrated compatibility with C-arm fluoroscopy, providing adequate contrast visualization. The total material cost per unit was 47.32 United States dollars (USD), compared to 180,000-250,000 USD for commercial virtual reality simulators. The model withstood 50 sessions without structural failure (onion bulb replacement was required every 8.2±1.4 precut attempts). Expert ratings indicated high scores for anatomical realism (4.1±0.6), tactile feedback (3.9±0.7), and educational value (4.4±0.5). CONCLUSIONS: This novel, low-cost ERCP simulator demonstrated technical feasibility and face validity. This proof-of-concept requires formal prospective validation studies to establish construct validity, concurrent validity, and educational effectiveness through trainee learning outcomes before conclusions regarding the impact on clinical training can be drawn. The innovation addresses significant accessibility barriers but represents preliminary evidence that requires formal educational validation.