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Efficacy of Fistulotomy for Biliary Cannulation

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 1, 2022 to Dec 1, 2026
    • Study completion date: Dec 3, 2022 to Dec 1, 2026
    • Site details revised
    v5
  2. Primary completion date: Mar 1, 2022 to Oct 1, 2022
    • Study completion date: Sep 3, 2022 to Dec 3, 2022
    v4
  3. Primary completion date: Jun 1, 2021 to Mar 1, 2022
    • Study completion date: Sep 3, 2021 to Sep 3, 2022
    v3
  4. Primary completion date: Mar 3, 2020 to Jun 1, 2021
    • Study completion date: Jul 3, 2020 to Sep 3, 2021
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04037007
Lead Sponsor Coordinación de Investigación en Salud, Mexico
Conditions
(from sponsor)		 Cholangiocarcinoma, Choledocholithiasis; Cholangitis, Pancreatic Cancer, Pancreatitis
Related terms Cholangiocarcinoma, Cholangitis, Choledocholithiasis, Pancreatic Neoplasms, Pancreatitis
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov