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

July 20, 2009
October 18, 2010
January 2009
April 2010   (final data collection date for primary outcome measure)
Stent migration rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00945516 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Feasibility [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Removability [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bile Duct Disease
  • 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)
  • 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)
Park do H, 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.
 
Completed
60
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00945516
2009-0233
Yes
Jung Sin Lee / the director of a center, Asan Medical Center
Asan Medical Center
Not Provided
Study Director: Do Hyun Park, MD, PhD Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Asan Medical Center
October 2010

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