Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees

Study Overview
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Brief Summary
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Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.

Official Title
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Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study

Conditions
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Selective Cannulation Rate of Trainees Receiving ERCP Training

Intervention / Treatment
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* Device: Hands-on EMS training
* Other: Standard training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consecutive inpatients with naive papilla undergoing ERCP. Exclusion Criteria: history of partial or total gastrectomy (Billroth I/II, Roux-en-Y); duodenal stricture (benign or melignant); ampullary carcinoma; previously failed selective cannulation; chronic pancreatitis with PD stone; minor papilla cannulation; servere diseases of heart, lung, brain and kidney; hemodynamical unstablility; pregnant women; refusal or unable to give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hands-on EMS training group<br> | Device: Hands-on EMS training<br>* A trainer (SAH) gave a series of demonstrations of the proper techniques of ERCP step by step on the EMS. The demonstration included selective cannulation, sphincterotomy, guidewire exchange, balloon dilation, stone extraction and stent insertion. Then trainees practiced each technique with hands-on coaching from the trainer on the EMS. Each trainee could repeate the practice with the trainer giving only verbal correction of any errors for about 30min.<br>Other: Standard training<br>* The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of CBD or PD. During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within 10min, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.<br>|
| Active Comparator: Standard training group<br> | Other: Standard training<br>* The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of CBD or PD. During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within 10min, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of selective cannulation in 10min by trainee |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time of successful cannulation |  | 2 years | 
| Cumulative success rate of each month |  | 2 years | 
| Performance score of selective cannulation |  | 2 years | 
| Performance score of EST |  | 2 years | 
| Complication rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, trainning, trainees, EMS