Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training

Study Overview
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Brief Summary
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Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skills and need at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. Traditional hands-on ERCP training requires the trainer to be on-site to assist the trainee with ERCP operations. We hypothesized that the trainee can be safely guided by trainer off-site with interactive audio and endoscopic and fluoroscopic view. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. Teleguidance facilitated ERCP cannulation is a strategy to provide expert cannulation guidance to trainee in settings where such expertise is not on-site. Teleguidance not only reduces unnecessary radiation exposure of endoscopist, but also provides remote assistance for trainees to complete training or further improve skills. Given the advantages of the off-site teleguidance, it could be an attractive substitute for on-site hands-on ERCP training. The primary aim of this study was to evaluate whether off-site assistance (Off group) could achieve a comparable success rate to on-site assistance (On group) regarding the rates of successful selective biliary cannulation during ERCP training.

Official Title
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Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial

Conditions
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ERCP Training, Biliary Tract Diseases, Pancreatic Diseases

Intervention / Treatment
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* Procedure: Off-site assistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 years old With native papilla Exclusion Criteria: History of partial or total gastrectomy (Billroth I/II, Roux-en-Y) Type II duodenal stenosis Previously failed cannulation Chronic pancreatitis with stones in the pancreatic head Hemodynamic instability Lactating or pregnant women Inability 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off-site assistance group<br>The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom. The trainer was not allowed to enter the procedure room and touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation. | Procedure: Off-site assistance<br>* The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom.<br>|
| No Intervention: On-site assistance group<br>The trainer supervised the trainee's cannulation operation in the procedure room. The trainer was allowed to provide unlimited verbal instructions to the trainee on-site. The trainer was not allowed to touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of selective cannulation by trainee | The rate of successful selective cannulation by trainee during the training period. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery）; Bleeding (mild, moderate, severe); | up to one year | 
| Performance score of selective cannulation | The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better | up to one year | 
| Final success rate of cannulation | The overall rate of successful selective cannulation by trainee and trainer | up to one year | 
| Total time of successful cannulation | Total time required for successful cannulation | up to one year | 
| Radiation exposure time | Radiation exposure time for trainee and trainer | up to one year |