Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation
|ClinicalTrials.gov Identifier: NCT01271179|
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : January 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Transplant Recipient||Procedure: sequential perfusion with ipv Ross solution and UW solution Procedure: sole perfusion with UW solution||Not Applicable|
The exact etiology of nonanastomotic biliary strictures (NAS) with a patent hepatic artery after liver transplantation remains unclear so far. Microangiopathy is strongly suspected to be involved in the etiology, so sufficient flushing of peribiliary plexus (PBP) which directly nourishes the donor biliary tree may be pivotal to prevent NAS with a patent hepatic artery.
Solution of University of Wisconsin (UW solution) is a standard for liver graft flushing, but accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which together constitutes a hindrance to solution penetration and thorough flushing of liver microcirculation including PBP. Several studies have revealed the relationship of high viscosity of UW solution with the development of NAS.
The investigators, therefore, have hypothesized that sequential perfusion with low-viscosity and high-viscosity preservation solutions might improve the patency of PBP in contrast with conventional sole perfusion with high-viscosity UW solution, and as a result, the incidence of NAS with a patent hepatic artery after liver transplantation would be significantly decreased.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: sequential perfusion
sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.
Procedure: sequential perfusion with ipv Ross solution and UW solution
Totally 6 L of ipv Ross solution were initially infused (aortic: portal=1:1), followed by 2 L of cold UW solution infusion (aortic: portal=1:1).
Placebo Comparator: sole perfusion
sole perfusion of liver grafts with high-viscosity UW solution only
Procedure: sole perfusion with UW solution
Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
- Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion [ Time Frame: 1 week ]PNF is defined as non-life-sustaining function of the graft unexplained by vascular complications or rejection, leading to death or retransplantation within postoperative 7 days.
- Number of participants with nonanastomotic biliary strictures with a patent hepatic artery [ Time Frame: 5 years ]nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.
- Number of participants with initial poor function (IPF) [ Time Frame: 1 week ]IPF is defined as a delayed function restoration with serum AST level greater than 2,000 U/L and prothrombin time greater than 16 seconds postoperative days 2 to 7.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271179
|Shanghai First People's Hospital|
|Shanghai, Shanghai, China, 200080|
|Study Director:||Zhi-Hai Peng, Prof.||Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|