Status:
COMPLETED
Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction
Lead Sponsor:
University of British Columbia
Conditions:
Malignant Tumor of Extrahepatic Bile Duct
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be ...
Detailed Description
Biliary obstruction usually presents with jaundice, pruritis, cholangitis, and steatorrhoea. Strictures which are a common cause of biliary obstruction, may be secondary to benign or malignant conditi...
Eligibility Criteria
Inclusion
- \> 18 years of age
- Bile duct stricture confirmed on cholangiography at ERCP
- Malignant etiology confirmed on histology or cytology
- Duct stricture is \> 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)
Exclusion
- Unable to obtain consent
- Unable to tolerate procedure
- Hilar strictures
- Known benign biliary strictures and benign strictures confirmed after randomization
- Circumstances where an alternative biliary stent (pigtail stent or metal stent) is deemed critical by the treating Gastroenterologist
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01514214
Start Date
January 1 2012
End Date
September 1 2016
Last Update
May 2 2018
Active Locations (2)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5