nilateral versus bilateral endoscopic biliary drainage for unresectable malignant hilar obstruction: a multicenter randomized controlled trial (BRILLIANT Trial)
Phase 3
Completed
- Conditions
- nresectable malignant hilar biliary obstruction
- Registration Number
- JPRN-UMIN000007859
- Lead Sponsor
- Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 166
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients after gastrectomy with Roux-en-Y reconstruction or Billroth II reconstruction. 2) Patients with marked hemiliver atrophy or patients after hepatectomy. 3) Separate obstructions of fourth-order or smaller biliary branches. 4) Patients with severe acute cholangitis. 5) Pregnant or breast-feeding women. 6) Patients considered ineligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Step 1 Functional success rate (Successful drainage was defined as reduction in bilirubin to <50% of the pretreatment value or normalization within 1 week after drainage.) Step 2 Time to stent dysfunction (ingrowth, overgrowth, sludge formation, and cholangitis)
- Secondary Outcome Measures
Name Time Method Step 1 1) Technical success rate 2) Bilirubin decrease rate 3) Complication rate 4) Additional drainage rate Step 2 1) Technical success rate 2) Early and late complications 3) Stent patency period 4) Survival period 5) Success rate of reintervention