A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation (REDLIT)
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|ClinicalTrials.gov Identifier: NCT02423941|
Recruitment Status : Unknown
Verified December 2016 by Republican Scientific and Practical Center for Organ and Tissue Transplantation.
Recruitment status was: Recruiting
First Posted : April 22, 2015
Last Update Posted : January 4, 2017
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:
- retrograde caval, followed by sequential portal-arterial, reperfusion or
- antegrade, sequential portal-arterial reperfusion.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Reperfusion Delayed Graft Function||Procedure: Retrogade reperfusion Procedure: Antegrade reperfusion||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: Retrograde reperfusion
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.
Procedure: Retrogade reperfusion
Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Other Name: Caval reperfusion
Active Comparator: Antegrade reperfusion
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.
Procedure: Antegrade reperfusion
Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Other Name: Conventional sequential portal-arterial reperfusion
- Incidence and severity of early graft dysfunction (EAD) [ Time Frame: 1-7 postoperative days ]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.
- Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels [ Time Frame: 24 and 48 hours post reperfusion ]
- Incidence of biliary strictures (anastomotic and nonanastomotic) [ Time Frame: 90 days after liver transplant procedure ]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.
- Incidence of in-hospital mortality [ Time Frame: 90 days after liver transplant procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423941
|Contact: Aliaksei E Shcherba, PhDemail@example.com|
|RSPC for organ and tissue transplantation, Minsk 9th clinic||Recruiting|
|Minsk, Belarus, 220116|
|Contact: Aliaksei E Shcherba, PhD +375293330689 firstname.lastname@example.org|
|Contact: Denis F Efimov +375(29)6884415 email@example.com|
|Principal Investigator: Aliaksei E Shcherba, PhD|
|Sub-Investigator: Andrew F Minou|
|Sub-Investigator: Evgeni O Santotski|
|Sub-Investigator: Alexander M Dzyadzko, PhD|
|Sub-Investigator: Denis J Efimov|
|Sub-Investigator: Sergei V Korotkov, PhD|
|Sub-Investigator: Oleg O Rummo, MD PhD|
|Study Chair:||Oleg O Rummo, MD PhD||RSPC for organ and tissue transplantation, Minsk 9th clinic|