Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study

Conditions
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Training

Intervention / Treatment
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* Device: ERCP mechanical simulator practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastrointestinal fellows receiving ERCP training Exclusion Criteria: Gastrointestinal fellows who are not receiving ERCP training

Ages Eligible for Study
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Minimum Age: 30 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERCP mechanical simulator practice<br>Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) | Device: ERCP mechanical simulator practice<br>* Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training<br>|
| No Intervention: No ERCP mechanical simulator practice<br>Trainees undergoing routine ERCP training only (control group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic biliary cannulation and deep biliary cannulation success rates | The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trainer assessment | Subjective competency (5-point score) graded by supervising physicians. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMS, ERCP, Training, Trainees