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

Not Applicable

Recruiting

• Conditions: ERCP Training; Biliary Tract Diseases; Pancreatic Diseases

• 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

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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