Comparison of bilateral and bilateral with tri-segmental endoscopic drainage for high-grade malignant hilar biliary obstructions
Phase 3
Recruiting
- Conditions
- High-grade malignant hilar biliary obstructionsHigh grade malignant hilar biliary obstructions, Bilataral drainageBile Duct Neoplasms
- Registration Number
- JPRN-jRCTs062220038
- Lead Sponsor
- Kato Hironari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
1. Unresectable malignant hilar biliary obstructions with Bismuth type IIIa or IV
2. Age over 18
3. Patient with fully informed consent
Exclusion Criteria
1. Reconstructed bowel other than Billroth 1
2. Inferior border of the biliary stricture extends close to the duodenal papilla which required stenting across the papilla Vater.
3. Endoscopic drainage will be ineffective due to severely divided bile duct, or severe portal vein invasion due to multiple liver metastasis. .
4. Radical resection, radiation therapy, and proton/particle therapy will be planned
5. Patient with pregnant or possibly pregnant.
6. Patient who are not expected to live 1 month or longer
7. Patient judged by the investigator to be inappropriate to enroll.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method non-recurrent biliary obstruction (non-RBO) rate
- Secondary Outcome Measures
Name Time Method Technical Success, Clinical Success, Time to RBO, Cause of RBO, Complications other than RBO, Duration of procedure, Time to RBO by EST, Overall Survival, Technical Success and Clinical Success at Re-intervention