Status:
RECRUITING
Efficacy of Fistulotomy for Biliary Cannulation
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Cholangiocarcinoma
Choledocholithiasis; Cholangitis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 difficu...
Detailed Description
Endoscopic Retrograde Pancreatography Cholangiography (ERCP) is the standard procedure for the treatment of pathologies that affect the bile duct. Approaching to the ampulla followed by deep selective...
Eligibility Criteria
Inclusion
- All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.
Exclusion
- 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.
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04037007
Start Date
July 3 2019
End Date
December 1 2026
Last Update
May 1 2025
Active Locations (1)
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1
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico, 06700