Anatomical endoscopic retrograde cholangiopancreatography simulator using moulded meshed silicone: A novel simulator pilot study

Abstract

Introduction: Endoscopic retrograde cholangio-pancreatography (ERCP) has higher rates of morbidity and mortality compared to upper or lower gastrointestinal tract endoscopy. The availability of magnetic resonance cholangiopancreatography means ERCP is usually performed for therapeutic purposes. Simulation could provide an adjunct to patient-based training in ERCP however models to date have been unconvincing. Methods: This ERCP simulation model was constructed from moulded meshed silicone by co-designers: Jean Wong and Kai Cheng. The anatomical orientation was based on a combination of anatomical specimens, sectional atlases, and the clinical experience of expert endoscopists. Results: From March to October 2022, we recruited 5 surgeons/gastroenterologists to the expert group and 14 medical students, junior doctors, or surgical/gastroenterological trainees to the novice group. Most experts either agreed or strongly agreed that the simulation anatomy appearance (100%), anatomical orientation (83%), tactile feedback (66%), traversal actions (67%), cannula positioning (66%) and papilla cannulation (67%) resembled the procedure in humans. Experts statistically significantly outperformed novices in obtaining a cannulating position (80% vs. 14%, P = 0.006) and successful papilla cannulation (80% vs. 7%, P = 0.0015) on their first attempt. The novice group had statistically significant improvements in time to obtaining a cannulating position (3.53 vs. 11.5 min, P = 0.006) and passing the duodenoscope to the papilla (2.55 vs. 4 passes, P = 0.009). Conclusions: The simulator showed statistically significant results in face, content, and construct validity. A follow-up validation study should recruit participants across multiple institutions. External validity could be assessed by comparing expert proceduralist simulator performance against clinical ERCP performance.