Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
- Conditions
- ERCP TrainingBiliary Tract DiseasesPancreatic Diseases
- Interventions
- Procedure: Off-site assistance
- Registration Number
- NCT05249400
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Age 18-90 years old
- With native papilla
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Off-site assistance group Off-site assistance 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.
- Primary Outcome Measures
Name Time Method Success rate of selective cannulation by trainee up to one year The rate of successful selective cannulation by trainee during the training period.
- Secondary Outcome Measures
Name Time Method Final success rate of cannulation up to one year The overall rate of successful selective cannulation by trainee and trainer
Total time of successful cannulation up to one year Total time required for successful cannulation
Performance score of selective cannulation up to one year The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better
Radiation exposure time up to one year Radiation exposure time for trainee and trainer
Complication rate up to one year Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery）; Bleeding (mild, moderate, severe);
Trial Locations
- Locations (1)
Endoscopic center, Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China