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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

Tracking Information
First Submitted Date  ICMJE July 20, 2009
First Posted Date  ICMJE July 24, 2009
Last Update Posted Date October 19, 2010
Study Start Date  ICMJE January 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
Stent migration rate [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00945516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
  • Feasibility [ Time Frame: one year ]
  • Safety [ Time Frame: one year ]
  • Removability [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Official Title  ICMJE Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bile Duct Disease
Intervention  ICMJE
  • 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)
  • Device: Hanarostent® (Anchoring FCSEMS)
    Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
    Other Name: Hanarostent® (M.I.Tech, Seoul, Korea)
Study Arms  ICMJE
  • Active Comparator: Flared end FCSEMS
    Flared end FCSEMS will be inserted for the benign bile duct stricture.
    Intervention: Device: Bona stent® (Flared end FCSEMS)
  • Active Comparator: Anchoring FCSEMS
    Anchoring FCSEMS will be inserted for benign bile duct stricture
    Intervention: Device: Hanarostent® (Anchoring FCSEMS)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 23, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945516
Other Study ID Numbers  ICMJE 2009-0233
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jung Sin Lee / the director of a center, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Do Hyun Park, MD, PhD Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
PRS Account Asan Medical Center
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP