- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945516
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
October 18, 2010 updated by: Asan Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flared end FCSEMS
Flared end FCSEMS will be inserted for the benign bile duct stricture.
|
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
Other Names:
|
Active Comparator: Anchoring FCSEMS
Anchoring FCSEMS will be inserted for benign bile duct stricture
|
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stent migration rate
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility (Technical success rate and functional success rate)
Time Frame: one year
|
one year
|
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
Time Frame: one year
|
one year
|
Removability
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Do Hyun Park, MD, PhD, Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
July 20, 2009
First Submitted That Met QC Criteria
July 23, 2009
First Posted (Estimate)
July 24, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2010
Last Update Submitted That Met QC Criteria
October 18, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-0233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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