ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- proportion of endoscopic sphincterotomy successfully performed by trainees
研究概览
简要总结
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.
详细描述
Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GI trainees who met the minimum endoscopy training experience
排除标准
- •GI trainees with no endoscopy experience
研究组 & 干预措施
study group
Simulation and lecture
干预措施: Simulation and lecture (Other)
control group
Lecture only
干预措施: Lecture (Other)
结局指标
主要结局
proportion of endoscopic sphincterotomy successfully performed by trainees
时间窗: 1year
次要结局
- Improvement in overall performance as measured by sphincterotomy score(1 year)