肝脏移植中的低温机器灌注 - 一项随机试验。

Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial.

机构信息

From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.

出版信息

N Engl J Med. 2021 Apr 15;384(15):1391-1401. doi: 10.1056/NEJMoa2031532. Epub 2021 Feb 24.

DOI:10.1056/NEJMoa2031532

PMID:33626248

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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

背景

来源于心跳停止供体的肝脏移植与非吻合口胆管狭窄的风险增加相关。肝脏低温氧合机器灌注可降低胆管并发症的发生率，但前瞻性对照研究的数据有限。

方法

在这项多中心对照试验中，我们将接受来源于心跳停止供体的肝脏移植的患者随机分配，接受肝脏低温氧合机器灌注（机器灌注组）或单纯常规冷保存（对照组）。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。

结果

共纳入 160 例患者，其中 78 例接受了机器灌注肝脏，78 例仅接受了静态冷保存肝脏（4 例患者在本试验中未接受肝脏）。机器灌注组患者中有 6%发生非吻合口胆管狭窄，对照组患者中有 18%发生非吻合口胆管狭窄（风险比，0.36；95%置信区间[CI]，0.14 至 0.94；P=0.03）。机器灌注组 12%的受者发生再灌注综合征，对照组 27%的受者发生再灌注综合征（风险比，0.43；95%CI，0.20 至 0.91）。机器灌注组早期移植物功能障碍发生率为 26%，对照组为 40%（风险比，0.61；95%CI，0.39 至 0.96）。与对照组相比，机器灌注后非吻合口胆管狭窄的治疗累积次数减少近 4 倍。两组不良事件发生率相似。