Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
NCT ID: NCT01339078
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2011-09-30
2015-12-31
Brief Summary
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The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months).
No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plastic stenting
Patients will be randomized towards plastic stenting.
Plastic stenting
The patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year.
Kaffes stenting
Patients will be randomized towards Kaffes stenting.
Kaffes stenting
The patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year.
Interventions
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Plastic stenting
The patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year.
Kaffes stenting
The patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year.
Eligibility Criteria
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Inclusion Criteria
* diagnosis established by :
* elevated liver tests
* a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
* no acute or chronic rejection
* no Cytomegalovirus (CMV) infection
* no other possible causes of elevated liver tests
* confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.
Exclusion Criteria
* absence of informed consent
* Roux-en-Y construction
* Living related liver transplantation patients.
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Hans Van Vlierberghe, Ph.D., M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital, Ghent
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2011/255
Identifier Type: -
Identifier Source: org_study_id