Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study|
- Diagnostic biliary cannulation and deep biliary cannulation success rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation
- Trainer assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Subjective competency (5-point score) graded by supervising physicians.
|Study Start Date:||July 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: ERCP mechanical simulator practice
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)
Device: ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
No Intervention: No ERCP mechanical simulator practice
Trainees undergoing routine ERCP training only (control group).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080833
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Joseph W Leung, MD||Sacramento VA Medical Center|