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Completed

NCT Number: NCT02105181

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

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.

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Key information

Conditions

Biliary Stricture Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of a FCMS in the biliary tract of the patients

Device

During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture

Primary outcomes

  1. Initial success rate of temporary FCMS placement

    Time frame: 6 months

    Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS

Secondary outcomes

  1. Final success

    Time frame: 18 months

    Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.

  2. Stricture recurrence

    Time frame: 18 months

    Both clinically and ERCP-documented recurrence of stricture after an initial success.

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2014
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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