NCT00945516

Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bile Duct Disease

Interventions

Type	Name	Description
DEVICE	Bona stent® (Flared end FCSEMS)	Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
DEVICE	Hanarostent® (Anchoring FCSEMS)	Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-07-24
• Last updated: 2010-10-19

Locations

1 site across 1 country: South Korea