Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures

April 6, 2014 updated by: Chaput Ulriikka, Société Française d'Endoscopie Digestive

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

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

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

  • France
      • Paris, France, 75014
        • Hôpital Cochin

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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
Device: Placement of a FCMS in the biliary tract of the 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

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Endoscopie Digestive

Investigators

  • Principal Investigator: Frederic Prat, MD, PhD, Société Française d'Endoscopie Digestive

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

March 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 6, 2014

Last Verified

April 1, 2014

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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