Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

Phase 3

Completed

• Conditions: Bile Duct Disease
• Interventions: Device: Bona stent® (Flared end FCSEMS); Device: Hanarostent® (Anchoring FCSEMS)

• 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-18
• Last Update Posted: 2010-10-19

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

Arm && Interventions

Group	Intervention	Description
Flared end FCSEMS	Bona stent® (Flared end FCSEMS)	Flared end FCSEMS will be inserted for the benign bile duct stricture.
Anchoring FCSEMS	Hanarostent® (Anchoring FCSEMS)	Anchoring FCSEMS will be inserted for benign bile duct stricture

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