Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

Study Overview
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Brief Summary
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To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

Detailed Description
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Practicing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the EMS provides opportunities for novice endoscopists to learn basic ERCP skills without a patient. In two randomized controlled trials (RCT), coached EMS practice increased selective bile duct cannulation success rate of novice endoscopists. Surgical trainees do not have sufficient endoscopy experience to meet the perceived basic requirement for ERCP training. However, ERCP is done with a side-viewing scope and even experienced GI trainees have difficult initially mastering the basic skill with scope manipulation and cannulation. It is not known whether EMS can provide additional benefit to novice surgical ERCP trainees.

Official Title
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Practice With ERCP Mechanical Simulator (EMS) Improves Basic ERCP Skills of Novice Surgical Trainees

Conditions
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Hands-on Training

Intervention / Treatment
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* Device: ERCP Mechanical Simulator (EMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No experienced surgical trainees receiving ERCP training Exclusion Criteria: Experienced surgical ERCP trainees or who are not receiving ERCP training

Ages Eligible for Study
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Minimum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Intensive EMS training group<br>Device: ERCP mechanical simulator training EMS group was coached (by JWL) on how to use the EMS, and then practiced with supervision by a senior surgeon biliary endoscopist (WBM). Trainees practiced for a total of 20 hours performing basic maneuvers including scope insertion 2 hours, scope positioning 6 hours, selective guide wire cannulation of common bile duct (CBD) stricture or pancreatic duct (PD) 10 hours and placement of a biliary stent 2 hours. All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over. | Device: ERCP Mechanical Simulator (EMS)<br>* Hands on EMS training<br>|
| No Intervention: Routine ERCP training group<br>Other: Routine ERCP training group All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of bile duct cannulation | Trainees received verbal instructions, hands-on assistance from the trainer no more than three times in performing the clinical procedure. The trainer took over if the trainee still failed after 20 minutes. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time before cannulation | during the scope explored to cannulation | 12 months | 
| Successful cannulation time from first achieve the papilla | the time between the first achieve the papilla to cannulate successfully | 12 months | 
| Total time | From scope explored to withdraw | 12 months | 
| performance score of selective cannulation | The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation | 12 months | 
| Complication rate | The rate of major complications | 12 months | 
| Trainer assessment | Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, EMS, Cannulation, Successful rate, Trainee