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.
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.
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).
Among patients with end-stage liver disease, IFLT significantly reduced complications related to IRI compared to a conventional approach.
chictr.org. ChiCTR1900021158.
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.
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.
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).
Among patients with end-stage liver disease, IFLT significantly reduced complications related to IRI compared to a conventional approach.
chictr.org. ChiCTR1900021158.
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.
摘要：
目的：缺血再灌注损伤（IRI）迄今被认为是器官移植的一个不可避免的组成部分，妥协的结果，限制器官的可用性。无缺血器官移植是一种旨在避免IRI的新方法，有可能改善结果。
方法：在本随机分组中，对照临床试验,脑死亡后供者的肝脏受者被随机分配接受无缺血或常规移植.主要终点是早期同种异体移植功能障碍的发生率。次要终点包括与移植物IRI相关的并发症。
结果：68例随机患者中有65例接受了移植并纳入分析。32例患者接受了无缺血肝移植（IFLT），33例接受常规肝移植（CLT）。早期同种异体移植功能障碍发生在2（6％）随机分配至IFLT和8（24％）随机分配至CLT（差异，-18%；95%CI，-35%至-1%；P=0.044）。再灌注综合征发生在3例（9％）随机分配到IFLT和21例（64％）随机分配到CLT（差异，-54%；95%CI，-74%至-35%；P<.001）。在随机接受IFLT的2例（8％）和随机接受CLT的9例（36％）中观察到12个月时通过协议磁共振胰胆管造影诊断出的非吻合胆管狭窄（差异，-28%；95%CI，-50%至-7%；P=0.014）。移植后一年的综合并发症指数IFLT组为30.48（95％CI，23.25-37.71），CLT组为42.14（95％CI，35.01-49.26）（差异，-11.66；95%CI，-21.81至-1.51；P=0.025）。
结论：在终末期肝病患者中，IFLT,与传统方法相比，显著减少与缺血再灌注损伤相关的并发症。
背景：Chictr.org.ChiCTR1900021158影响和意义：缺血再灌注损伤迄今被认为是器官移植中不可避免的事件，影响结果和限制器官的可用性。无缺血肝移植是一种在不中断血液供应的情况下移植供体肝脏的新方法。我们发现在终末期肝病患者中,无缺血肝移植,在这项随机试验中,与常规方法相比,与缺血再灌注损伤相关的并发症减少.这种新方法有望改变目前的器官移植实践，改善移植结果。增加器官利用率，同时提供了一个临床模型来描述器官损伤对同种免疫的影响。
方法：在本随机分组中，对照临床试验,脑死亡后供者的肝脏受者被随机分配接受无缺血或常规移植.主要终点是早期同种异体移植功能障碍的发生率。次要终点包括与移植物IRI相关的并发症。
结果：68例随机患者中有65例接受了移植并纳入分析。32例患者接受了无缺血肝移植（IFLT），33例接受常规肝移植（CLT）。早期同种异体移植功能障碍发生在2（6％）随机分配至IFLT和8（24％）随机分配至CLT（差异，-18%；95%CI，-35%至-1%；P=0.044）。再灌注综合征发生在3例（9％）随机分配到IFLT和21例（64％）随机分配到CLT（差异，-54%；95%CI，-74%至-35%；P<.001）。在随机接受IFLT的2例（8％）和随机接受CLT的9例（36％）中观察到12个月时通过协议磁共振胰胆管造影诊断出的非吻合胆管狭窄（差异，-28%；95%CI，-50%至-7%；P=0.014）。移植后一年的综合并发症指数IFLT组为30.48（95％CI，23.25-37.71），CLT组为42.14（95％CI，35.01-49.26）（差异，-11.66；95%CI，-21.81至-1.51；P=0.025）。
结论：在终末期肝病患者中，IFLT,与传统方法相比，显著减少与缺血再灌注损伤相关的并发症。
背景：Chictr.org.ChiCTR1900021158影响和意义：缺血再灌注损伤迄今被认为是器官移植中不可避免的事件，影响结果和限制器官的可用性。无缺血肝移植是一种在不中断血液供应的情况下移植供体肝脏的新方法。我们发现在终末期肝病患者中,无缺血肝移植,在这项随机试验中,与常规方法相比,与缺血再灌注损伤相关的并发症减少.这种新方法有望改变目前的器官移植实践，改善移植结果。增加器官利用率，同时提供了一个临床模型来描述器官损伤对同种免疫的影响。
