Efficacy of Fistulotomy for Biliary Cannulation
Recruiting · NCT04037007 · Interventional (participants receive a specific treatment) · Lead sponsor: Coordinación de Investigación en Salud, Mexico
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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.
Where it is running
1 location listed.
- Centro Medico Nacional Siglo XXI Hospital de Especialidades - Mexico City, Mexico City, Mexico