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

S

Société Française d'Endoscopie Digestive

Status

Completed

Conditions

Biliary Stricture

Treatments

Device: Placement of a FCMS in the biliary tract of the patients

Study type

Interventional

Funder types

Other

Identifiers

NCT02105181
2006-A00197-44

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

92 participants in 1 patient group

Fully covered metal stent (FCMS)
Other group
Description:
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
Treatment:
Device: Placement of a FCMS in the biliary tract of the patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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