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

Société Française d'Endoscopie Digestive92 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biliary Stricture

Interventions

Placement of a FCMS in the biliary tract of the patientsDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Cochin

Paris, France

Outcomes

Primary Outcomes

Initial success rate of temporary FCMS placement

Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS

Time frame: 6 months

Secondary Outcomes

Final success

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

Stricture recurrence

Both clinically and ERCP-documented recurrence of stricture after an initial success.

Time frame: 18 months

Data from ClinicalTrials.gov

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