Comparing two techniques for accessing the bile duct in patients with biliary diseases
Official title: Efficacy and Safety of Precut Fistulotomy vs Conventional Cannulation Technique as a Primary Approach to Biliary Access According to the Endoscopist Experience Degree in ERCP
Run by Coordinación de Investigación en Salud, Mexico · NCT04037007 · Data updated 2026-11-12
This study is testing two different methods for accessing the bile duct to see which one works better for patients with biliary diseases like cholangiocarcinoma and choledocholithiasis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Status | Recruiting |
| Started | July 3, 2019 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | May 1, 2025 |
| Trial ID | NCT04037007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing ERCP with suspected or confirmed biliary conditions such as choledocholithiasis or biliary stenosis.
✕Probably not a fit
Patients with previous ERCP, altered gastro-duodenal anatomy, or certain malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the efficacy of two techniques for biliary cannulation: fistulotomy and conventional guidewire cannulation. It will involve a randomized prospective design, assessing outcomes based on the experience level of the endoscopists performing the procedures. The study will focus on patients with conditions such as cholangiocarcinoma and choledocholithiasis, evaluating success rates and complications associated with each technique. The trial will take place at the gastrointestinal endoscopy department of a major hospital in Mexico City.
Why it matters
Potential benefit: If successful, this study could improve the success rates of biliary cannulation, leading to better treatment outcomes for patients with biliary diseases.
How similar studies have gone: Previous studies have shown that early precut techniques can improve cannulation success rates, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis. Exclusion Criteria: * patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5. Elimination Criteria: \- Incomplete procedure due to anesthesia adverse events.
Where it's running
-
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico Recruiting
Study contacts
- Principal investigator: Oscar V Hernandez Mondragon, MD — Instituto Mexicano del Seguro Social
- Study coordinator: Oscar V Hernández Mondragón, MD
- Email: mondragonmd@yahoo.co.uk
- Phone: +525556276900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.