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

December 30, 2010
January 5, 2011
July 2004
December 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01271179 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Liver Transplantation
  • Transplant Recipient
  • 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).
  • Procedure: sole perfusion with UW solution
    Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
  • Active Comparator: sequential perfusion
    sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.
    Intervention: Procedure: sequential perfusion with ipv Ross solution and UW solution
  • Placebo Comparator: sole perfusion
    sole perfusion of liver grafts with high-viscosity UW solution only
    Intervention: Procedure: sole perfusion with UW solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01271179
SFPH04618
Yes
Zhi-Hai Peng/ vice-president of Shanghai First People's Hospital, Shanghai First People's Hospital
Shanghai Jiao Tong University School of Medicine
Not Provided
Study Director: Zhi-Hai Peng, Prof. Shanghai First People's Hospital
Shanghai Jiao Tong University School of Medicine
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP