Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study

Asan Medical Center1 site in 1 country60 target enrollmentJanuary 2009

ConditionsBile Duct Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bile Duct Disease
Sponsor: Asan Medical Center
Enrollment: 60
Locations: 1
Primary Endpoint: Stent migration rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stent migration rate

Time Frame: one year

Secondary Outcomes

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)