Training Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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