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Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

NCT ID: NCT00945516

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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

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Bile Duct Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flared end FCSEMS

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

Group Type ACTIVE_COMPARATOR

Bona stent® (Flared end FCSEMS)

Intervention Type DEVICE

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

Anchoring FCSEMS

Anchoring FCSEMS will be inserted for benign bile duct stricture

Group Type ACTIVE_COMPARATOR

Hanarostent® (Anchoring FCSEMS)

Intervention Type DEVICE

Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Interventions

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Bona stent® (Flared end FCSEMS)

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

Intervention Type DEVICE

Hanarostent® (Anchoring FCSEMS)

Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Intervention Type DEVICE

Other Intervention Names

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Bona stent® (Sewoon medical Co., LTD., Seoul, Korea) Hanarostent® (M.I.Tech, Seoul, Korea)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center

Principal Investigators

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Do Hyun Park, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

Locations

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Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011 Jan;73(1):64-70. doi: 10.1016/j.gie.2010.09.039.

Reference Type DERIVED
PMID: 21184871 (View on PubMed)

Other Identifiers

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2009-0233

Identifier Type: -

Identifier Source: org_study_id