Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

Bile Duct Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945516
• Other study ID #: 2009-0233
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2009
• Last updated: October 18, 2010
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Disease
• Bile Duct Diseases

Intervention

Device:
• Bona stent® (Flared end FCSEMS)
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
• Hanarostent® (Anchoring FCSEMS)
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent migration rate		one year	Yes
Secondary	Feasibility (Technical success rate and functional success rate)		one year	Yes
Secondary	Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)		one year	Yes
Secondary	Removability		one year	Yes