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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential perfusion | Active Comparator | sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution. |
|
| sole perfusion | Placebo Comparator | sole perfusion of liver grafts with high-viscosity UW solution only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-Hai Peng, Prof. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12619026 | Background | 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. | |
| 11443584 | 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. |
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| sole perfusion with UW solution | Procedure | Totally 6 L of cold UW solution were infused (aortic: portal =1:1) |
|
| 8477965 | 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. |
| ID | Term |
|---|---|
| C055206 | University of Wisconsin-lactobionate solution |
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