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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Stricture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Placement of a FCMS in the biliary tract of the patients

Intervention Type DEVICE

During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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 .