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

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105181
• Other study ID #: 2006-A00197-44
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: April 6, 2014
• Start date: March 2007
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial success rate of temporary FCMS placement	Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS	6 months	No
Secondary	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	No
Secondary	Stricture recurrence	Both clinically and ERCP-documented recurrence of stricture after an initial success.	18 months	No