A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)
Phase 3
- Conditions
- Malignant common bile duct obstruction
- Registration Number
- JPRN-C000000043
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
o significant difference of the patency of bile duct between bare stent group and covered stent group at 24 weeks after stent placement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Post choledocho-intestinal anatomosis, hepatocellular carcinoma, duodenal cancer, peritoneal carcinomatosis, mucin-producing tumor. 2) Duodenal or intestinal obstruction. 3) Biliary infection. 4) Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patency of bile duct at 24 weeks after stent placement.
- Secondary Outcome Measures
Name Time Method Technical success rate of tube removal and adverse events