Comparing two techniques for accessing the bile duct in patients with biliary diseases
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT04037007 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing ERCP with suspected or confirmed biliary conditions such as choledocholithiasis or biliary stenosis.
Not a fit: Patients with previous ERCP, altered gastro-duodenal anatomy, or certain malignancies may not benefit from this study.
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 performed: Previous studies have shown that early precut techniques can improve cannulation success rates, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
Mexico City, Mexico City
- 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
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.