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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde reperfusion | Experimental | During the transplant procedure the liver is initially reperfused retrogradely via hepatic veins. Venting of 300 ml blood is allowed via donor portal vein. After completion the portal vein anastomosis and retrograde venting of another 100 ml blood the antegrade portal reperfusion is performed. |
|
| Antegrade reperfusion | Active Comparator | During the transplant procedure the liver is reperfused conventionally, antegradely via portal vein after completion of caval and portal anastomoses. Venting of 300 ml blood is allowed via tube placed in infrahepatiс caval anastomosis before unclamping the vena cava. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrogade reperfusion | Procedure | Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 1-7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels | 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. |
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Donor Inclusion Criteria:
Recipient inclusion Criteria:
Technique of liver transplant:
Recipient exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliaksei E Shcherba, PhD | Contact | +375293330689 | aleina@tut.by |
| Name | Affiliation | Role |
|---|---|---|
| Oleg O Rummo, MD PhD | RSPC for organ and tissue transplantation, Minsk 9th clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSPC for organ and tissue transplantation, Minsk 9th clinic | Recruiting | Minsk | 220116 | Belarus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20677285 | Background | Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091. | |
| 23579740 | Background | Salvalaggio P, Afonso RC, Felga G, Ferraz-Neto BH. A proposal to grade the severity of early allograft dysfunction after liver transplantation. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):23-31. doi: 10.1590/s1679-45082013000100006. |
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Antegrade reperfusion | Procedure | Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion. |
|
|
| 90 days after liver transplant procedure |
| Incidence of in-hospital mortality | 90 days after liver transplant procedure |
| Background | Designing Clinical Research/Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013.-367p.] |