Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training

Not Applicable

Completed

• Conditions: Training
• Interventions: Device: ERCP mechanical simulator practice

• Registration Number: NCT01080833
• Lead Sponsor: East Bay Institute for Research and Education

Brief Summary

Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Detailed Description

Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Hypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.

STUDY DESIGN \& OUTCOMES

* Controlled randomized observational study.

* Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied

* Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Gastrointestinal fellows receiving ERCP training

Exclusion Criteria

• Gastrointestinal fellows who are not receiving ERCP training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP mechanical simulator practice	ERCP mechanical simulator practice	Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)

Primary Outcome Measures

Name	Time	Method
Diagnostic biliary cannulation and deep biliary cannulation success rates	12 months	The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation

Secondary Outcome Measures

Name	Time	Method
Trainer assessment	12 months	Subjective competency (5-point score) graded by supervising physicians.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States