A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation
Study Overview
Brief Summary
In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.
Detailed Description
Background: The impact of mechanical simulator practice on clinical ERCP performance has not been reported.
Hypothesis
Practice with mechanical simulator improves clinical ERCP performance of novice trainees.
Design: A prospective randomized controlled trial.
Method: 8 trainees without prior ERCP experience from 2 hospitals attended didactic lectures on ERCP. They were randomized in pairs (per hospital) to receive simulator practice and usual training (S) versus usual training only as control (C). Simulator practice included selective bile and pancreatic duct cannulation using a catheter and/or guide wire with different artificial papillae (flat, standard, dual channels) and settings (standard, rotated papilla or duodenum), and exchange of guide wire/accessories and biliary stenting. Local trainers tracked trainees' subsequent clinical ERCP performance for 3 months. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation. Trainer blinded to the randomization provided assessment (1=poor, 5=excellent) of each trainee performed ERCP.
Statistics: Fisher exact test and Mann-Whitney U test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •GI trainees who met the minimum endoscopy training experience
Exclusion Criteria
- •GI trainees with no endoscopy experience
Outcomes
Primary Outcomes
Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation
Time Frame: 3 months
Secondary Outcomes
- Trainer blinded to the randomization provided assessment of each trainee performed ERCP(3 months)