Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP

Not Applicable

Recruiting

• Conditions: ERCP Training

• Registration Number: NCT06197815
• 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 skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. It required the trainer to stand by the trainee in the procedure room to assist. There were insufficient patients for most trainees to achieve competence until the trainee graduate. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. We hypothesized that the trainee can be safely guided by a senior trainer off-site with the endoscopic view displayed on a screen. Using the teleguidance, the trainer can even continue to provide guidance when the trainees complete their training and return to their hospitals until they achieve the recommended clinical competency. Given the advantages of the off-site teleguidance, it could be an attractive substitute for hands-on assistance to ERCP training.

The primary aim of this study was to evaluate whether off-site assistance (OA group) could achieve a comparable success rate to standard hands-on assistance (HA group) with regard to the rates of successful selective biliary cannulation during ERCP training.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2023-12-27
• Status Verified: 2024-01
• Study First Posted: 2024-01-09
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 754

Inclusion Criteria

1. Patients aged 18-90 years who received ERCP
2. Patients with native papilla

Exclusion Criteria

1. Patients with altered anatomy (Billroth I/II, Roux-en-Y)
2. Type II duodenal stenosis
3. Previously failed cannulation
4. Chronic pancreatitis with stones in the pancreatic head
5. Hemodynamic instability
6. Lactating or pregnant women
7. Inability to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of successful biliary cannulation	10 minutes	The percentage of trainee successfully biliary cannulation

Secondary Outcome Measures

Name	Time	Method
Competency score from the trainer and endoscopic video	1 day
Incidences of PEP and other adverse events	1 month
Ionizing radiation time	1 day
Cannulation time	1 day

Trial Locations

Locations (3)

Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China

Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China