NCT01080833

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

Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: East Bay Institute for Research and Education · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Training

Interventions

Type	Name	Description
DEVICE	ERCP mechanical simulator practice	Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2010-03-04
• Last updated: 2010-03-19

Locations

1 site across 1 country: United States