A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Inoperable Tumors of the Bile Duct
Both
Inoperable Tumors of the Bile Duct
Trial Information
A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Inclusion Criteria:
- greater than 18 years of age.
- Malignant bile duct stricture.
- Increased bilirubin.
- Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common
hepatic duct into the right and left hepatic ducts).
- Not an operative candidate.
Exclusion Criteria:
- Unable to obtain consent.
- Unable to tolerate procedure.
- Suspected benign bile duct stricture.
- Candidate for potentially curative surgical intervention.
- Previous metallic biliary stent.
- Previous bile duct surgery.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
David L Carr-Locke, MD, FRCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brigham and Women's Hospital
Authority:
United States: Institutional Review Board
Study ID:
BS-816
NCT ID:
NCT01047332
Start Date:
August 2002
Completion Date:
December 2010
Related Keywords:
- Inoperable Tumors of the Bile Duct
- Cholestasis
- Constriction, Pathologic
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