Actively Recruiting
Efficacy of Fistulotomy for Biliary Cannulation
Led by Coordinación de Investigación en Salud, Mexico · Updated on 2025-05-01
320
Participants Needed
1
Research Sites
386 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Efficacy of Fistulotomy for Biliary Cannulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ERCP with suspected or confirmed choledocholithiasis or malignant and benign biliary stenosis
You will not qualify if you...
- Previous ERCP procedure
- Altered gastro-duodenal anatomy due to prior surgery
- Suspicion or diagnosis of ampullary neoplasm
- Duodenal cancer
- Periampullary diverticula types 1 and 2
- Pregnancy
- Coagulopathy with INR greater than 1.5
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico, 06700
Actively Recruiting
Research Team
O
Oscar V Hernández Mondragón, MD
CONTACT
C
Carlos Mendoza Segura, Fellow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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