Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00945516
First received: July 20, 2009
Last updated: October 18, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


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
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
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

No publications provided by Asan Medical Center

Additional 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
Study First Received: July 20, 2009
Last Updated: October 18, 2010
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

Additional relevant MeSH terms:
Bile Duct Diseases
Cholestasis
Constriction, Pathologic
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014