Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period

Study Overview
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Brief Summary
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In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

Detailed Description
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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.

Official Title
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A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance

Conditions
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Patients Undergoing ERCP Examination

Intervention / Treatment
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* Device: simulator training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GI trainees who met the minimum endoscopy training experience Exclusion Criteria: GI trainees with no endoscopy experience
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 half-day of simulator ERCP practice and usual training | Device: simulator training<br>* 4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training<br>|
| Active Comparator: 2<br>Usual training | Device: simulator training<br>* 4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trainer blinded to the randomization provided assessment of each trainee performed ERCP |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical simulator, ERCP, training