Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation

Shanghai Jiao Tong University School of Medicine141 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

141

Conditions

Liver Transplantation Transplant Recipient

Interventions

sequential perfusion with ipv Ross solution and UW solutionPROCEDURE

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).

sole perfusion with UW solutionPROCEDURE

Totally 6 L of cold UW solution were infused (aortic: portal =1:1)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion

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.

Time frame: 1 week

Number of participants with nonanastomotic biliary strictures with a patent hepatic artery

nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.

Time frame: 5 years

Secondary Outcomes

Number of participants with initial poor function (IPF)

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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