Status:
COMPLETED
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Lead Sponsor:
Asan Medical Center
Conditions:
Bile Duct Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
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 s...
Eligibility Criteria
Inclusion
- Patient over 18 years old
- Patient with benign bile duct stricture
Exclusion
- No written informed consent
- Malignant biliary obstruction
- Patients with uncorrectable severe coagulopathy
- Patients with severe cardiopulmonary disease precluding sedation
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00945516
Start Date
January 1 2009
End Date
May 1 2010
Last Update
October 19 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-736