Status:
COMPLETED
Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation
Lead Sponsor:
University of Southern California
Conditions:
Cholestasis, Extrahepatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer. 2. Given the small siz...
Detailed Description
1.0 BACKGROUND Bile duct access is the most difficult part of endoscopic retrograde cholangiography (ERCP) performed for the biliary indications of bile duct stones, leak, and stricture. In the past ...
Eligibility Criteria
Inclusion
- Undergoing ERCP at LAC+USC Medical Centers for standard indications including bile duct stones, bile leak, and biliary obstruction will be included.
Exclusion
- Prior ERCP with sphincterotomy
- Prior ERCP with failed bile duct cannulation
- Pregnant, imprisoned, under age 18, unable to give informed consent
- Prior biliary diversion surgery will be excluded
- Those who require ERCP only for pancreatic duct indications will also be excluded as bile duct cannulation is not clinically necessary in this group
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT02197338
Start Date
April 1 2016
End Date
April 1 2016
Last Update
April 15 2016
Active Locations (1)
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1
Los Angeles County Hospital
Los Angeles, California, United States, 90033