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Completed

NCT Number: NCT01271179

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sequential perfusion with ipv Ross solution and UW solution

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 with UW solution

Procedure

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 5 years

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

Secondary outcomes

  1. Number of participants with initial poor function (IPF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2011
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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