Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
Study Details
Study Description
Brief Summary
Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Plastic stenting Patients will be randomized towards plastic stenting. |
Procedure: 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.
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| Experimental: Kaffes stenting Patients will be randomized towards Kaffes stenting. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Comparison of patency of the bile duct between normal and Kaffes stenting. [after 6 months and after 1 year]
Comparison of patency of the bile duct 6 months after 1 year of stenting. Patency is defined as the presence of normal liver function test (direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT), alkaline phosphatase) and non-dilated bile ducts on Magnetic resonance cholangiopancreatography (MRCP). In the presence of cytomegalovirus (CMV) infection, rejection or other causes of possible disturbed liver function parameters, the MRCP findings rule over the lab tests.
Secondary Outcome Measures
- safety of the Kaffes stent [during a period of 1 year]
The safety of the Kaffes stent, compared to the normal stent will be assessed (e.g. change of stents, blood tests, endoscopic retrograde cholangio-pancreatography (ERCP)).
- Duration of hospitalization [during a period of 1 year]
- Number of stent changes [during a period of 1 year]
Patients included in the plastic stenting arm will receive change of stents every 3 months for a total duration of 1 year. Patients included in the Kaffes stent arm will receive change of the stent every 6 months for a total duration of 1 year. In case the patient develops symptoms of stent occlusion (rise of liver tests, fever, septicimiae), the stent will be changed as soon as possible.
- Comparison of costs between normal stenting and Kaffes stenting. [during a period of 1 year]
Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
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diagnosis established by :
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elevated liver tests
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a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
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no acute or chronic rejection
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no Cytomegalovirus (CMV) infection
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no other possible causes of elevated liver tests
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confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.
Exclusion Criteria:
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non-anastomotic strictures
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absence of informed consent
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Roux-en-Y construction
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Living related liver transplantation patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital, Ghent | Ghent | Belgium |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Hans Van Vlierberghe, Ph.D., M.D., University Hospital, Ghent
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2011/255