Efficacy of Fistulotomy for Biliary Cannulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCoordinación de Investigación en Salud, Mexico

About this trial

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

Qualifiers

All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

320 Participants
are divided into 4 treatment groups