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Efficacy of Fistulotomy for Biliary Cannulation

RecruitingNAAges 18 Years - 90 YearsAllCoordinación de Investigación en Salud, Mexico
NCT04037007 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Fistulotomy - High experienced.
  • Fistulotomy - Low experienced.
  • Conventional (guidewire) cannulation- High experienced
  • Conventional (guidewire) cannulation - Low experienced
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Where

1 site
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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