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Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

This study has been completed.
Information provided by:
Asan Medical Center Identifier:
First received: July 20, 2009
Last updated: October 18, 2010
Last verified: October 2010
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: 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.

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

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 identifier: NCT00945516

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
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 Identifier (NCT Number):
Responsible Party: Jung Sin Lee / the director of a center, Asan Medical Center Identifier: NCT00945516     History of Changes
Other Study ID Numbers: 2009-0233
Study First Received: July 20, 2009
Last Updated: October 18, 2010

Keywords provided by Asan Medical Center:
Metal stent
Bile duct stricture
Stent migration

Additional relevant MeSH terms:
Constriction, Pathologic
Bile Duct Diseases
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases processed this record on April 27, 2017