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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic stenting | Active Comparator | Patients will be randomized towards plastic stenting. |
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| Kaffes stenting | Experimental | Patients will be randomized towards Kaffes stenting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plastic stenting | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of patency of the bile duct between normal and Kaffes stenting. | 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. | after 6 months and after 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| safety of the Kaffes stent | 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)). | during a period of 1 year |
| Duration of hospitalization |
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Inclusion Criteria:
Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
diagnosis established by :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Van Vlierberghe, Ph.D., M.D. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Ghent | Ghent | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Kaffes stenting | Procedure | 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. |
|
| during a period of 1 year |
| Number of stent changes | 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. | during a period of 1 year |
| Comparison of costs between normal stenting and Kaffes stenting. | Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated. | during a period of 1 year |