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

Not Applicable

Completed

• Conditions: Biliary Stricture
• Interventions: Device: Placement of a FCMS in the biliary tract of the patients

• Registration Number: NCT02105181
• Lead Sponsor: Société Française d'Endoscopie Digestive

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-06
• Study First Posted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fully covered metal stent (FCMS)	Placement of a FCMS in the biliary tract of the patients	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

Primary Outcome Measures

Name	Time	Method
Initial success rate of temporary FCMS placement	6 months	Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS

Secondary Outcome Measures

Name	Time	Method
Final success	18 months	Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.
Stricture recurrence	18 months	Both clinically and ERCP-documented recurrence of stricture after an initial success.

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France