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

Not Applicable

Completed

• Conditions: Liver Transplantation; Transplant Recipient

• Registration Number: NCT01271179
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2004-07
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2011-01-05
• Last Update Submitted: 2011-01-05
• Study First Posted: 2011-01-06
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China