Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training (ERCP)
|ClinicalTrials.gov Identifier: NCT01080833|
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : March 19, 2010
|Condition or disease||Intervention/treatment|
|Training||Device: ERCP mechanical simulator practice|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||July 2008|
|Primary Completion Date :||June 2009|
|Study Completion Date :||December 2009|
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).
- Diagnostic biliary cannulation and deep biliary cannulation success rates [ Time Frame: 12 months ]The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation
- Trainer assessment [ Time Frame: 12 months ]Subjective competency (5-point score) graded by supervising physicians.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080833
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Joseph W Leung, MD||Sacramento VA Medical Center|