Trial Information
Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial
Inclusion Criteria:
- Patient over 18 years old
- Patient with malignant hilar obstruction
Exclusion Criteria:
- No written informed consent
- Patient with uncorrectable severe coagulopathy
- Indication for surgical operation
- Karnofsky score < 60%
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Stent patency
Outcome Description:
Interval time (d) from stent insertion to occlusion
Outcome Time Frame:
Up to 2 years
Safety Issue:
Yes
Authority:
Korea: Institutional Review Board
Study ID:
SCH-2010-04
NCT ID:
NCT01125865
Start Date:
May 2010
Completion Date:
December 2011
Related Keywords:
- Bile Duct Obstruction
- Klatskin's Tumor
- Malignant hilar stricture
- Cholestasis
- Klatskin's Tumor
- Constriction, Pathologic
