A prospective randomized comparative trial of covered self-expandable metallic stents with 12mm and 10mm diameters for the distal biliary obstructions in unresectable malignancies
Phase 2
- Conditions
- unresectable distal biliary malignancies
- Registration Number
- JPRN-UMIN000016911
- Lead Sponsor
- BORE Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with massive ascites 2) patients with severe comorbidities in other organs 3) prior biliary SEMS placement 4) patients with surgically altered anatomy 5) difficulty to achieve biliary cannulation during endoscopic retrograde cholangiography 6) intestinal obstruction distal to the ampulla 7) patients with pregnancy 8) patients considered ineligible by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent occlusion rate and dysfunction rate at 180 days after stent deployment
- Secondary Outcome Measures
Name Time Method 1) Stent patency duration 2) Time to recurrent biliary obstruction (TRBO) 3) Overall stent patency rate and function rate 4) Median survival time 5) Stent-related complication rate