Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
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|ClinicalTrials.gov Identifier: NCT02105181|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Stricture||Device: Placement of a FCMS in the biliary tract of the patients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Fully covered metal stent (FCMS)
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
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
- 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
- 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.
- Stricture recurrence [ Time Frame: 18 months ]Both clinically and ERCP-documented recurrence of stricture after an initial success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105181
|Paris, France, 75014|
|Principal Investigator:||Frederic Prat, MD, PhD||Societe Francaise d'Endoscopie digestive|