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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplantation Transplant Recipient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sequential perfusion

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

Group Type ACTIVE_COMPARATOR

sequential perfusion with ipv Ross solution and UW solution

Intervention Type PROCEDURE

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

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

Group Type PLACEBO_COMPARATOR

sole perfusion with UW solution

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type PROCEDURE

sole perfusion with UW solution

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No