- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105181
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.
The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Hopital Cochin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a history of liver transplantation, chronic pancreatitis or biliary surgery
- impairment of liver function tests such as elevated liver enzymes and/or cholestasis
- a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .
Exclusion Criteria:
- an uncertainty about the benign nature of the stricture
- an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fully covered metal stent (FCMS)
There is one arm in the study : the intervention consists on placing a device which is a fully covered metal stent in the biliary tract of all patients
|
During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial success rate of temporary FCMS placement
Time Frame: 6 months
|
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Final success
Time Frame: 18 months
|
Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.
|
18 months
|
Stricture recurrence
Time Frame: 18 months
|
Both clinically and ERCP-documented recurrence of stricture after an initial success.
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frederic Prat, MD, PhD, Société Française d'Endoscopie Digestive
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-A00197-44
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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