NCT02105181

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Stricture

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-04-07
• Last updated: 2014-04-08

Locations

1 site across 1 country: France