A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture
Not Applicable
- Conditions
- Advenced biliary tract cancer
- Registration Number
- JPRN-UMIN000005182
- Lead Sponsor
- Kawasaki Medical Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1. Performance status is 4. 2. ASA calassification is over 3. 3. Informed consent is not achieved. 4. Patients considered ineligible for this study. 5. The prognosis is considered within three months. 6. Patients who recieved additional treatment after initial unilateral drainage with naso-biliary plastic stents 7. Left or right lobe is occupied by the tumor. 8. Transpapillary deployment of metallic stents is not achieved.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method duration from stent deployment to re-intervention
- Secondary Outcome Measures
Name Time Method 1. over all survival 2. complication rate 3. rate of stent patency at death 4. rate of application of endoscopic re-intervention to first stent occlusion and success rate of the intervention