{Reference Type}: Randomized Controlled Trial
{Title}: A randomized-controlled trial of ischemia-free liver transplantation for end-stage liver disease.
{Author}: Guo Z;Zhao Q;Jia Z;Huang C;Wang D;Ju W;Zhang J;Yang L;Huang S;Chen M;Zhu X;Hu A;Ma Y;Wu L;Chen Y;Han M;Tang Y;Wang G;Wang L;Li L;Xiong W;Zhang Z;Shen Y;Tang Z;Zhu C;Chen X;Hu X;Guo Y;Chen H;Ma Y;Zhang T;Huang S;Zeng P;Lai S;Wang T;Chen Z;Gong J;Yu J;Sun C;Li C;Tan H;Liu Y;Dong Y;Sun C;Liao B;Ren J;Zhou Z;Andrea S;Björn N;Cai C;Gong F;Rong J;Huang W;Guan X;Clavien PA;Stefan TG;Huang J;He X;
{Journal}: J Hepatol
{Volume}: 79
{Issue}: 2
{Year}: 2023 08 20
{Factor}: 30.083
{DOI}: 10.1016/j.jhep.2023.04.010
{Abstract}: Ischemia-reperfusion injury (IRI) has thus far been considered as an inevitable component of organ transplantation, compromising outcomes, and limiting organ availability. Ischemia-free organ transplantation is a novel approach designed to avoid IRI, with the potential to improve outcomes.<BR>In this randomized-controlled clinical trial, recipients of livers from donors after brain death were randomly assigned to receive either an ischemia-free or a 'conventional' transplant. The primary endpoint was the incidence of early allograft dysfunction. Secondary endpoints included complications related to graft IRI.<BR>Out of 68 randomized patients, 65 underwent transplants and were included in the analysis. 32 patients received ischemia-free liver transplantation (IFLT), and 33 received conventional liver transplantation (CLT). Early allograft dysfunction occurred in two recipients (6%) randomized to IFLT and in eight (24%) randomized to CLT (difference -18%; 95% CI -35% to -1%; p = 0.044). Post-reperfusion syndrome occurred in three recipients (9%) randomized to IFLT and in 21 (64%) randomized to CLT (difference -54%; 95% CI -74% to -35%; p <0.001). Non-anastomotic biliary strictures diagnosed with protocol magnetic resonance cholangiopancreatography at 12 months were observed in two recipients (8%) randomized to IFLT and in nine (36%) randomized to CLT (difference, -28%; 95% CI -50% to -7%; p = 0.014). The comprehensive complication index at 1 year after transplantation was 30.48 (95% CI 23.25-37.71) in the IFLT group vs. 42.14 (95% CI 35.01-49.26) in the CLT group (difference -11.66; 95% CI -21.81 to -1.51; p = 0.025).<BR>Among patients with end-stage liver disease, IFLT significantly reduced complications related to IRI compared to a conventional approach.<BR>chictr.org. ChiCTR1900021158.<BR>Ischemia-reperfusion injury has thus far been considered as an inevitable event in organ transplantation, compromising outcomes and limiting organ availability. Ischemia-free liver transplantation is a novel approach of transplanting donor livers without interruption of blood supply. We showed that in patients with end-stage liver disease, ischemia-free liver transplantation, compared with a conventional approach, led to reduced complications related to ischemia-reperfusion injury in this randomized trial. This new approach is expected to change the current practice in organ transplantation, improving transplant outcomes, increasing organ utilization, while providing a clinical model to delineate the impact of organ injury on alloimmunity.