荷兰格罗宁根大学医学中心Robert J. Porte团队研究了低温机械灌注在肝移植中的应用效果。2021年2月24日，该研究发表在《新英格兰医学杂志》上。

循环死亡后供体肝脏移植与非吻合性胆道狭窄的风险增加相关。低温氧合机械灌注肝脏可降低胆道并发症的发生率，但前瞻性对照研究的数据有限。

在这项多中心、对照试验中，研究组随机将接受供体循环死亡后肝脏移植的患者分为低温氧合机械灌注组（机械灌注组）和传统静态冷藏组（对照组）。主要终点为移植后6个月内非吻合性胆道狭窄的发生率，次要终点包括其他移植物相关和一般并发症。

研究组共纳入160名患者，其中78名接受了机械灌注肝脏移植，78名接受了静态冷藏后的肝脏移植（有4名患者未接受肝脏移植）。机械灌注组中有6%的患者发生非吻合性胆管狭窄，对照组中有18%，风险比为0.36，差异显著。机械灌注肝受者中有12%发生再灌注后综合征，对照组受者中有27%，风险比为0.43。机械灌注组肝脏中有26%出现早期同种异体移植功能障碍，对照组肝脏中有40%，风险比为0.61。与对照组相比，机械灌注后非吻合性胆管狭窄的累计治疗次数减少了近4倍。两组不良事件发生率相似。

研究结果表明，低温氧合机械灌注与传统静态冷藏相比，可显著降低循环死亡后供体肝脏移植后非吻合性胆道狭窄的风险。

附：英文原文

Title: Hypothermic Machine Perfusion in Liver Transplantation — A Randomized Trial

Author: Rianne van Rijn, M.D., Ph.D.,, Ivo J. Schurink, B.Sc.,, Yvonne de Vries, M.D., Ph.D.,, Aad P. van den Berg, M.D., Ph.D.,, Miriam Cortes Cerisuelo, M.D., Ph.D.,, Sarwa Darwish Murad, M.D., Ph.D.,, Joris I. Erdmann, M.D, Ph.D.,, Nicholas Gilbo, M.D., Ph.D.,, Robbert J. de Haas, M.D., Ph.D.,, Nigel Heaton, M.D., Ph.D.,, Bart van Hoek, M.D., Ph.D.,, Volkert A.L. Huurman, M.D., Ph.D.,, Ina Jochmans, M.D., Ph.D.,, Otto B. van Leeuwen, Ph.D.,, Vincent E. de Meijer, M.D., Ph.D.,, Diethard Monbaliu, M.D., Ph.D.,, Wojciech G. Polak, M.D., Ph.D.,, Jules J.G. Slangen, M.D.,, Roberto I. Troisi, M.D., Ph.D.,, Aude Vanlander, M.D., Ph.D.,, Jeroen de Jonge, M.D., Ph.D.,, and Robert J. Porte, M.D., Ph.D.

Issue&Volume: 2021-02-24

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.

DOI: 10.1056/NEJMoa2031532

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2031532