CompletedNot Applicable

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

France92 participantsStarted 2007-03

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Initial success rate of temporary FCMS placement

Timeframe: 6 months

Trial details

NCT IDNCT02105181

SponsorSociété Française d'Endoscopie Digestive

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Biliary Stricture trials