Comparing off-site and hands-on assistance for ERCP training
Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study
NA · Air Force Military Medical University, China · NCT06197815
This study is testing whether remote guidance from experienced trainers can help medical trainees learn how to perform ERCP procedures better than traditional hands-on help.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 754 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Air Force Military Medical University, China (other) |
| Locations | 3 sites (Chongqing, Chongqing and 2 other locations) |
| Trial ID | NCT06197815 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of off-site teleguidance versus traditional hands-on assistance for trainees performing endoscopic retrograde cholangiopancreatography (ERCP). The hypothesis is that experienced trainers can guide trainees remotely using a live endoscopic view displayed on a screen, potentially allowing for more efficient training. The study aims to determine if this method can help trainees achieve competency in ERCP more effectively than conventional methods. The research is conducted across multiple hospitals in China, focusing on patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18-90 years who are undergoing ERCP with a native papilla.
Not a fit: Patients with altered anatomy, chronic pancreatitis with stones, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the training of ERCP procedures, leading to better-trained gastroenterologists and improved patient outcomes.
How similar studies have performed: While the concept of remote guidance in medical training is gaining interest, this specific approach to ERCP training is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chongqing, Chongqing and 2 other locations
- Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University — Chongqing, Chongqing, China (RECRUITING)
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University — Xi'an, Shaanxi, China (RECRUITING)
- Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Yanglin Pan, MD
- Email: yanglinpan@hotmail.com
- Phone: 86-29-84771536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ERCP Training