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

NCT01271179 | Completed DMC

• 1 other identifier: SFPH04618
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Transplant Recipient

Keywords

orthotopic liver transplantation; preservation solution; peribiliary plexus; nonanastomotic biliary strictures; primary non-function

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Number of participants with initial poor function (IPF)

  1 week

Study Arms (2)

sequential perfusion

ACTIVE COMPARATOR

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

sole perfusion

PLACEBO COMPARATOR

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

Procedure: sole perfusion with UW solution

Interventions

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).

sequential perfusion

sole perfusion with UW solution PROCEDURE

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

sole perfusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥18 years
• ability to provide written informed consent prior to study entry
• receiving a whole liver graft
• primary transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related 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. doi: 10.1053/jlts.2003.50015.

  PMID: 12619026 BACKGROUND

• 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.

  PMID: 11443584 BACKGROUND

• 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.

  PMID: 8477965 BACKGROUND

MeSH Terms

Interventions

University of Wisconsin-lactobionate solution

Study Officials

• Zhi-Hai Peng, Prof.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 6, 2011
• Study Start: July 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 6, 2011

Record last verified: 2010-12

Locations

CN (1)