NCT04037007Recruiting
Efficacy of Fistulotomy for Biliary Cannulation
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
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (\> 200 ERCPs\[Endoscopic Retrograde cholangiopancreatography\]) and low experienced endoscopists (\< 200 ERCPs).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 26 Jul 2019
- Start date
- 3 Jul 2019
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- NCT number
- NCT04037007
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 3 Jul 2019 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Nacional Siglo XXI Hospital de Especialidades Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.