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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Asan Medical Center
Seoul, Seoul, South Korea
Stent migration rate
Time frame: one year
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
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