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

Primary Purpose

Liver Transplantation, Transplant Recipient

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sequential perfusion with ipv Ross solution and UW solution
sole perfusion with UW solution
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplantation focused on measuring orthotopic liver transplantation, preservation solution, peribiliary plexus, nonanastomotic biliary strictures, primary non-function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

sequential perfusion

sole perfusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
December 30, 2010
Last Updated
January 5, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01271179
Brief Title
Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Transplant Recipient
Keywords
orthotopic liver transplantation, preservation solution, peribiliary plexus, nonanastomotic biliary strictures, primary non-function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sequential perfusion
Arm Type
Active Comparator
Arm Description
sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution.
Arm Title
sole perfusion
Arm Type
Placebo Comparator
Arm Description
sole perfusion of liver grafts with high-viscosity UW solution only
Intervention Type
Procedure
Intervention Name(s)
sequential perfusion with ipv Ross solution and UW solution
Intervention Description
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
Intervention Name(s)
sole perfusion with UW solution
Intervention Description
Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
Primary Outcome Measure Information:
Title
Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion
Description
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.
Time Frame
1 week
Title
Number of participants with nonanastomotic biliary strictures with a patent hepatic artery
Description
nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of participants with initial poor function (IPF)
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, Prof.
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
12619026
Citation
Moench C, Moench K, Lohse AW, Thies J, Otto G. Prevention of ischemic-type biliary lesions by arterial back-table pressure perfusion. Liver Transpl. 2003 Mar;9(3):285-9. doi: 10.1053/jlts.2003.50015.
Results Reference
background
PubMed Identifier
11443584
Citation
Pirenne J, Van Gelder F, Coosemans W, Aerts R, Gunson B, Koshiba T, Fourneau I, Mirza D, Van Steenbergen W, Fevery J, Nevens F, McMaster P. Type of donor aortic preservation solution and not cold ischemia time is a major determinant of biliary strictures after liver transplantation. Liver Transpl. 2001 Jun;7(6):540-5. doi: 10.1053/jlts.2001.24641.
Results Reference
background
PubMed Identifier
8477965
Citation
Sanchez-Urdazpal L, Gores GJ, Ward EM, Maus TP, Buckel EG, Steers JL, Wiesner RH, Krom RA. Diagnostic features and clinical outcome of ischemic-type biliary complications after liver transplantation. Hepatology. 1993 Apr;17(4):605-9. doi: 10.1002/hep.1840170413.
Results Reference
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Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation

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