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Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

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ClinicalTrials.gov Identifier: NCT00945516
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : October 19, 2010
Sponsor:
Information provided by:
Asan Medical Center

Study Description
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Brief 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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010
Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Stent migration rate [ Time Frame: one year ]

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

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

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 Posted: July 24, 2009    Key Record Dates
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