Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Phase 3
Completed
- Conditions
- Bile Duct Disease
- Registration Number
- NCT00945516
- Lead Sponsor
- Asan Medical Center
- Brief Summary
The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.
- Detailed Description
Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Patient over 18 years old
- Patient with benign bile duct stricture
Exclusion Criteria
- No written informed consent
- Malignant biliary obstruction
- Patients with uncorrectable severe coagulopathy
- Patients with severe cardiopulmonary disease precluding sedation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stent migration rate one year
- Secondary Outcome Measures
Name Time Method Feasibility (Technical success rate and functional success rate) one year Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure) one year Removability one year
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of