In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications.
A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P = 0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups.
Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283.).
在这个多中心,对照试验,我们将循环性死亡后接受供体肝脏移植的患者随机分组,接受低温氧合机灌注后(机灌注组)或常规静态冷藏后(对照组)的肝脏移植.主要终点是移植后6个月内非吻合口胆管狭窄的发生率。次要终点包括其他移植物相关和一般并发症。
共纳入160名患者,其中78人接受了机器灌注的肝脏,78人仅在静态冷藏后接受了肝脏(本试验中有4例患者未接受肝脏)。非吻合性胆道狭窄发生在机器灌注组的6%的患者和对照组的18%的患者(风险比,0.36;95%置信区间[CI],0.14至0.94;P=0.03)。灌注后综合征发生在12%的机器灌注肝脏接受者和27%的对照组(风险比,0.43;95%CI,0.20至0.91)。早期同种异体移植功能障碍发生在26%的机器灌注肝脏中,与40%的对照肝脏(风险比,0.61;95%CI,0.39至0.96)。机器灌注后,非吻合口胆管狭窄的累积治疗次数降低了近4倍。与对照组相比。两组的不良事件发生率相似。
与常规静态冷藏相比,在循环性死亡后从供体获得的肝脏移植后,低温氧合机灌注导致非吻合性胆管狭窄的风险较低。(由FondsNutsOhra资助;DHOPE-DCDClinicalTrials.gov编号,NCT02584283。).