A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstructio
Phase 3
- Conditions
- Malignant biliary obstruction
- Registration Number
- JPRN-UMIN000008587
- Lead Sponsor
- Faculty of Medicine, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with massive ascites. 2) Patients with severely impaired organ function. 3) Patients for whom endoscopic biliary drainage is difficult. 4) Patients with duodenal obstruction. 5) Patients whose antithrombotic drugs cannot be stopped. 6) Patients considered ineligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to stent dysfunction
- Secondary Outcome Measures
Name Time Method Effectiveness 1) Stent patency period 2) Survival period 3) Event free survival 4) Stent patency period after reintervention 5) Time to stent dysfunction after reintervention 6) Cost effectiveness Safety 1) Early complications 2) Late complications 3) Technical success rate 4) Removability of the stent 5) Removability of the second stent