Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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


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


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 20, 2009
Last Updated:	October 18, 2010
Health Authority:	Korea: Ministry for Health and Welfare

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

ClinicalTrials.gov processed this record on September 23, 2016