Supplementary Material for: A novel dry simulator model for learning comprehensive endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy procedures while minimizing adverse bleeding events (with Video)

Background: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for endoscopic cholangio-pancreatic procedures. However, these procedures have a high incidence of adverse events, and most training is currently patient-based. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. Methods: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills such as papillary alignment and maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. Results: The novel simulator model comprises a disposable duodenal papillary portion, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct portions, designed for repeated use. The duodenal papillary portion enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct portion allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insert other devices. After training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]:55.5–76.5) to 85.5 (IQR: 78.0–92.0) (P<0.01). All participants expressed their desire for repeated simulator training sessions. Conclusions: This innovative simulator serves as a practical educational tool, particularly beneficial for novices in ERCP. It facilitates hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

研究背景：内镜逆行胰胆管造影术（Endoscopic retrograde cholangiopancreatography, ERCP）与内镜括约肌切开术（endoscopic sphincterotomy, EST）是内镜胰胆管操作的核心技能。然而此类操作不良事件发生率较高，当前多数培训仍依托真实患者开展。本研究旨在开发一款ERCP/EST模拟训练模型，以满足对更安全的训练替代方案的需求，尤其适用于ERCP操作经验有限的学习者。

研究方法：本模型设计初衷为支持实际内镜器械的使用，其学习目标与经过验证的贝塞斯达ERCP技能评估工具（Bethesda ERCP Skill Assessment Tool, BESAT）的考核模块高度契合。BESAT重点考核乳头对位、十二指肠镜位置维持、轻柔高效插管、正确路径下的控制性括约肌切开以及导丝操控等操作技能。2022年5月至2023年3月期间，共有30名消化科培训医师使用该模拟器，研究采用视觉模拟评分法（visual analog scale, VAS）及培训前后调查问卷对其满意度进行评估。

研究结果：这款新型模拟训练模型由可一次性使用的十二指肠乳头模块（适配电刀切开操作）与可重复使用的可清洗上消化道、胆管模块组成。十二指肠乳头模块可还原真实的内镜操作位置，并可模拟因切开不当引发的出血不良事件；胆管模块可模拟类似透视的影像效果，便于受训者练习导丝引导及其他器械置入操作。培训后，反映受训者对模型学习期望的VAS中位数评分从69.5（四分位距[IQR]：55.5~76.5）显著提升至85.5（IQR：78.0~92.0）（P<0.01）。所有受试者均表示希望能够多次使用该模拟器开展训练。

研究结论：本款创新性模拟器是一款实用的教学工具，尤其对ERCP新手颇具裨益。其支持使用真实器械开展实操练习，有助于提升操作熟练度，并加深对精准切开操作的理解，从而降低EST术中出血并发症的发生风险。