Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Bile Duct Disease

Treatments: Device: Hanarostent® (Anchoring FCSEMS); Device: Bona stent® (Flared end FCSEMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00945516

2009-0233

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Flared end FCSEMS

Active Comparator group

Description:

Flared end FCSEMS will be inserted for the benign bile duct stricture.

Treatment:

Device: Bona stent® (Flared end FCSEMS)

Anchoring FCSEMS

Active Comparator group

Description:

Anchoring FCSEMS will be inserted for benign bile duct stricture

Treatment:

Device: Hanarostent® (Anchoring FCSEMS)