Back to resultsNewly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Primary Purpose
Bile Duct Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bona stent® (Flared end FCSEMS)
Hanarostent® (Anchoring FCSEMS)
Sponsored by
About this trial
This is an interventional treatment trial for Bile Duct Disease focused on measuring Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Flared end FCSEMS
Anchoring FCSEMS
Arm Description
Flared end FCSEMS will be inserted for the benign bile duct stricture.
Anchoring FCSEMS will be inserted for benign bile duct stricture
Outcomes
Primary Outcome Measures
Stent migration rate
Secondary Outcome Measures
Feasibility (Technical success rate and functional success rate)
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
Removability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00945516
Brief Title
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Official Title
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Disease
Keywords
Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flared end FCSEMS
Arm Type
Active Comparator
Arm Description
Flared end FCSEMS will be inserted for the benign bile duct stricture.
Arm Title
Anchoring FCSEMS
Arm Type
Active Comparator
Arm Description
Anchoring FCSEMS will be inserted for benign bile duct stricture
Intervention Type
Device
Intervention Name(s)
Bona stent® (Flared end FCSEMS)
Other Intervention Name(s)
Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)
Intervention Description
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
Intervention Type
Device
Intervention Name(s)
Hanarostent® (Anchoring FCSEMS)
Other Intervention Name(s)
Hanarostent® (M.I.Tech, Seoul, Korea)
Intervention Description
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Primary Outcome Measure Information:
Title
Stent migration rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
Feasibility (Technical success rate and functional success rate)
Time Frame
one year
Title
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
Time Frame
one year
Title
Removability
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Organizational Affiliation
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21184871
Citation
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.
Results Reference
derived
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Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
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