Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT01339078|
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : April 20, 2011
Last Update Posted : June 3, 2015
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|
|Biliary Strictures Post Liver Transplantation.||Procedure: Plastic stenting Procedure: Kaffes stenting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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.
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.
- Comparison of patency of the bile duct between normal and Kaffes stenting. [ Time Frame: 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.
- safety of the Kaffes stent [ Time Frame: 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 [ Time Frame: during a period of 1 year ]
- Number of stent changes [ Time Frame: 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. [ Time Frame: during a period of 1 year ]Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339078
|Contact: Hans Van Vlierberghe, Ph.D. , M.D.||Hans.Vanvlierberghe@ugent.be|
|University Hospital, Ghent||Recruiting|
|Contact: Hans Van Vlierberghe, Ph.D. , M.D. Hans.Vanvlierberghe@ugent.be|
|Principal Investigator: Hans Van Vlierberghe, Ph.D. , M.D.|
|Principal Investigator:||Hans Van Vlierberghe, Ph.D. , M.D.||University Hospital, Ghent|