Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00945516

First Posted: July 24, 2009

Last Update Posted: October 19, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Asan Medical Center

Purpose

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.

Condition	Intervention	Phase
Bile Duct Disease	Device: Bona stent® (Flared end FCSEMS) Device: Hanarostent® (Anchoring FCSEMS)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Stent migration rate [ Time Frame: one year ]

Secondary Outcome Measures:

Feasibility (Technical success rate and functional success rate) [ Time Frame: one year ]
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure) [ Time Frame: one year ]
Removability [ Time Frame: one year ]


Estimated Enrollment:	60
Study Start Date:	January 2009
Study Completion Date:	May 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Flared end FCSEMS Flared end FCSEMS will be inserted for the benign bile duct stricture.	Device: Bona stent® (Flared end FCSEMS) Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP. Other Name: Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)
Active Comparator: Anchoring FCSEMS Anchoring FCSEMS will be inserted for benign bile duct stricture	Device: Hanarostent® (Anchoring FCSEMS) Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP. Other Name: Hanarostent® (M.I.Tech, Seoul, Korea)

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.

Eligibility

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945516

Locations


Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Asan Medical Center

Investigators


Study Director:	Do Hyun Park, MD, PhD	Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jung Sin Lee / the director of a center, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00945516 History of Changes
Other Study ID Numbers:	2009-0233
First Submitted:	July 20, 2009
First Posted:	July 24, 2009
Last Update Posted:	October 19, 2010
Last Verified:	October 2010

Keywords provided by Asan Medical Center:


Metal stent Bile duct stricture Stent migration	Feasibility Safety Removability

Additional relevant MeSH terms:


Constriction, Pathologic Bile Duct Diseases Pathological Conditions, Anatomical Biliary Tract Diseases Digestive System Diseases

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