Abstract：
Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited.
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.).
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.).
摘要：
循环性死亡后从供体获得的肝脏移植与非吻合口胆管狭窄的风险增加有关。肝脏低温氧合机灌注可降低胆道并发症的发生率，但是来自前瞻性的数据，对照研究有限。
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。).
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。).
