ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

Not Applicable

• Conditions: Endoscopic Sphincterotomy
• Interventions: Other: Simulation and lecture; Other: Lecture

• Registration Number: NCT02393638
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.

Detailed Description

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-02-10
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Posted: 2015-03-19
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• GI trainees who met the minimum endoscopy training experience

Exclusion Criteria

• GI trainees with no endoscopy experience

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Simulation and lecture	Simulation and lecture
control group	Lecture	Lecture only

Primary Outcome Measures

Name	Time	Method
proportion of endoscopic sphincterotomy successfully performed by trainees	1year

Secondary Outcome Measures

Name	Time	Method
Improvement in overall performance as measured by sphincterotomy score	1 year

Trial Locations

Locations (1)

Department of Gastroenterology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan