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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
Sponsor:
Information provided by (Responsible Party):
Chaput Ulriikka, Société Française d'Endoscopie Digestive

Brief 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.


Condition or disease Intervention/treatment Phase
Biliary Stricture Device: Placement of a FCMS in the biliary tract of the patients Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Cochin
Paris, France, 75014
Sponsors and Collaborators
Société Française d'Endoscopie Digestive
Investigators
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Principal Investigator: Frederic Prat, MD, PhD Societe Francaise d'Endoscopie digestive

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Responsible Party: Chaput Ulriikka, Dr Ulriikka Chaput, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT02105181     History of Changes
Other Study ID Numbers: 2006-A00197-44
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by Chaput Ulriikka, Société Française d'Endoscopie Digestive:
benign biliary stricture
anastomotic biliary stricture after liver transplantation
chronic pancreatitis
biliary surgical procedure
fully covered metal stent
Additional relevant MeSH terms:
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Cholestasis
Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases