To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction. All eligible enrolled liver transplant candidates will be randomized to receive either: 1. retrograde caval, followed by sequential portal-arterial, reperfusion or 2. antegrade, sequential portal-arterial reperfusion.
We hypothesize that retrograde caval reperfusion could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction. Chi-square method of sample size estimation with a=0,05, b=0,20 and P1-P2 = 0,25 required a 41 subject per group (Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams \& Wilkins, 2013). After signing the informed consent 90 patients will be randomized to study and active-control group (45 each). Only patients undergoing classical technique (retrohepatic IVC resection) of liver transplantation without vena-venous bypass will be enrolled to the study. In the study group after completion of both caval anastomoses (super and infra-hepatic) the infra-hepatic cava-clamp is released and removed allowing the filling and flushing the liver retrogradely through the hepatic veins. 300 ml of blood is drained via donor portal vein and the vein will be clamped. Suprahepatic cava-clamp is released and removed allowing venous return to the right atrium. Portal vein anastomosis will be constructed. Before the last 2-3 stitches another 100 ml will be drained retrogradely. Recipient portal vein clamp is removed and liver will be reperfused antegradely. After that arterial and biliary anastomoses will be constructed. In the control group cava-clamps are not removed until completion the portal vein anastomosis. Chi-square test and regression analysis will be used to test the difference in incidence of early allograft liver dysfunction in the study groups. Mann-Whitney test will be used to compare the median of highest aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 24 and 48 hours post-reperfusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
RSPC for organ and tissue transplantation, Minsk 9th clinic
Minsk, Belarus
RECRUITINGIncidence and severity of early graft dysfunction (EAD)
EAD will be assessed according to Olthoff KM, et al. Liver Transpl. 2010. Severe EAD will be assessed according to P.R. Salvalaggio, et al. Transplantation Proceedings, 2012.
Time frame: 1-7 postoperative days
Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Time frame: 24 and 48 hours post reperfusion
Incidence of biliary strictures (anastomotic and nonanastomotic)
All biliary strictures would be diagnosed by cholangiography, either ERCP or MRCP. Ulrtrasound will be used as a screening tool to assign a cholestatic patient to cholangiography.
Time frame: 90 days after liver transplant procedure
Incidence of in-hospital mortality
Time frame: 90 days after liver transplant procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.