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

Study Overview
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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.

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.

Official Title
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Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures

Conditions
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Biliary Stricture

Intervention / Treatment
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* Device: Placement of a FCMS in the biliary tract of the patients


Participation Criteria
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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 . Exclusion Criteria: an uncertainty about the benign nature of the stricture an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fully covered metal stent (FCMS)<br>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<br>* During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial success rate of temporary FCMS placement | 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 | 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 | Both clinically and ERCP-documented recurrence of stricture after an initial success. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent