A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer
- Conditions
- Biliary stricture caused by unresectable middle to lower bile duct cancer
- Registration Number
- JPRN-UMIN000009779
- Lead Sponsor
- Kansai Endoscopic Device Selection (EDS) Working Group
- Brief Summary
Reintervention was performed for recurrent biliary obstruction in 18 of 72 covered SEMSs (25%) and 28 of 71 uncovered SEMSs (39%). Median stent patency times were 552 days and 314 days for the covered and uncovered SEMSs groups, respectively. The log-rank test revealed that the stent patency time in the covered SEMSs group was significantly longer than that in the uncovered SEMSs group (P=0.041). Stent dysfunction developed in 17 (23%) patients in the covered SEMSs group and in 23 (38%) patients in the uncovered SEMSs group, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1) PS>4 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method