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

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Liver Transplantation; Transplant Recipient

Treatments: Procedure: sole perfusion with UW solution; Procedure: sequential perfusion with ipv Ross solution and UW solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01271179

SFPH04618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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141 participants in 2 patient groups, including a placebo group

sequential perfusion

Active Comparator group

Description:

sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.

Treatment:

Procedure: sequential perfusion with ipv Ross solution and UW solution

sole perfusion

Placebo Comparator group

Description:

sole perfusion of liver grafts with high-viscosity UW solution only

Treatment:

Procedure: sole perfusion with UW solution