Back to resultsFully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
Primary Purpose
Biliary Stricture
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Placement of a FCMS in the biliary tract of the patients
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Stricture focused on measuring benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent
Eligibility Criteria
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
Sites / Locations
- Hôpital Cochin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fully covered metal stent (FCMS)
Arm Description
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
Outcomes
Primary Outcome Measures
Initial success rate of temporary FCMS placement
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
Secondary Outcome Measures
Final success
Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.
Stricture recurrence
Both clinically and ERCP-documented recurrence of stricture after an initial success.
Full Information
NCT ID
NCT02105181
First Posted
April 2, 2014
Last Updated
April 6, 2014
Sponsor
Société Française d'Endoscopie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT02105181
Brief Title
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
Official Title
Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Société Française d'Endoscopie Digestive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Stricture
Keywords
benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fully covered metal stent (FCMS)
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Placement of a FCMS in the biliary tract of the patients
Intervention Description
During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture
Primary Outcome Measure Information:
Title
Initial success rate of temporary FCMS placement
Description
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Final success
Description
Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.
Time Frame
18 months
Title
Stricture recurrence
Description
Both clinically and ERCP-documented recurrence of stricture after an initial success.
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Prat, MD, PhD
Organizational Affiliation
Société Française d'Endoscopie Digestive
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
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