NCT04037007 Efficacy of Fistulotomy for Biliary Cannulation
| NCT ID | NCT04037007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Coordinación de Investigación en Salud, Mexico |
| Condition | Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2019-07-03 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2019-07-03 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Oscar V Hernandez Mondragon, MD
PRINCIPAL INVESTIGATOR
Instituto Mexicano del Seguro Social
Frequently Asked Questions
Who can join the NCT04037007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04037007 currently recruiting?
Yes, NCT04037007 is actively recruiting participants. Contact the research team at mondragonmd@yahoo.co.uk for enrollment information.
Where is the NCT04037007 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT04037007 clinical trial?
NCT04037007 is sponsored by Coordinación de Investigación en Salud, Mexico. The principal investigator is Oscar V Hernandez Mondragon, MD at Instituto Mexicano del Seguro Social. The trial plans to enroll 320 participants.