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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01271179
First received: December 30, 2010
Last updated: January 5, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention
Liver Transplantation
Transplant Recipient
Procedure: sequential perfusion with ipv Ross solution and UW solution
Procedure: sole perfusion with UW solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.


Secondary Outcome Measures:
  • Number of participants with initial poor function (IPF) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 141
Study Start Date: July 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sequential perfusion
sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.
Procedure: 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).
Placebo Comparator: sole perfusion
sole perfusion of liver grafts with high-viscosity UW solution only
Procedure: sole perfusion with UW solution
Totally 6 L of cold UW solution were infused (aortic: portal =1:1)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01271179

Locations
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Zhi-Hai Peng, Prof. Shanghai First People's Hospital
  More Information

Publications:
Responsible Party: Zhi-Hai Peng/ vice-president of Shanghai First People's Hospital, Shanghai First People's Hospital
ClinicalTrials.gov Identifier: NCT01271179     History of Changes
Other Study ID Numbers: SFPH04618
Study First Received: December 30, 2010
Last Updated: January 5, 2011
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
orthotopic liver transplantation
preservation solution
peribiliary plexus
nonanastomotic biliary strictures
primary non-function

Additional relevant MeSH terms:
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014