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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02105181
Other study ID # 2006-A00197-44
Secondary ID
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


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
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