Liver Transplantation, Transplant Recipient
Conditions
Keywords
orthotopic liver transplantation, preservation solution, peribiliary plexus, nonanastomotic biliary strictures, primary non-function
Brief summary
The study was designed to investigate whether, compared with conventional sole perfusion with high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts with low-viscosity and high-viscosity preservation solutions could further decrease the incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.
Detailed description
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.
Interventions
PROCEDUREsequential 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).
PROCEDUREsole perfusion with UW solution
Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age≥18 years * ability to provide written informed consent prior to study entry * receiving a whole liver graft * primary transplantation
Exclusion criteria
* participant in other clinical trials * fulminant liver failure as the cause of transplantation * primary biliary cirrhosis, autoimmune hepatitis or primary sclerosing cholangitis as primary liver disease * retransplantation * non-liver organ(s) failure prior to study entry * donor/recipient ABO-blood-group-incompatibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion | 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 | 5 years | nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with initial poor function (IPF) | 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. |
Countries
China
Outcome results
None listed