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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271179
• Other study ID #: SFPH04618
• Status: Completed
• Phase: N/A
• First received: December 30, 2010
• Last updated: January 5, 2011
• Start date: July 2004
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cholestasis
• Liver Transplantation
• Transplant Recipient

Intervention

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).
• sole perfusion with UW solution
Totally 6 L of cold UW solution were infused (aortic: portal =1:1)

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week	Yes
Primary	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.	5 years	No
Secondary	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.	1 week	Yes