Clinical Trial: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
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 Summary: 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.
Sponsor: Asan Medical Center
Current Primary Outcome: Stent migration rate [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Feasibility (Technical success rate and functional success rate) [ Time Frame: one year ]
- Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure) [ Time Frame: one year ]
- Removability [ Time Frame: one year ]
Original Secondary Outcome:
- Feasibility [ Time Frame: one year ]
- Safety [ Time Frame: one year ]
- Removability [ Time Frame: one year ]
Information By: Asan Medical Center
Dates:
Date Received: July 20, 2009
Date Started: January 2009
Date Completion:
Last Updated: October 18, 2010
Last Verified: October 2010
