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加拿大单中心人体常温体外肝脏灌注的初步经验:一项临床试验的结果

Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial.

作者信息

Bral M, Gala-Lopez B, Bigam D, Kneteman N, Malcolm A, Livingstone S, Andres A, Emamaullee J, Russell L, Coussios C, West L J, Friend P J, Shapiro A M J

机构信息

Department of Surgery, University of Alberta, Edmonton, Canada.

Members of the Canadian National Transplant Research Project (CNTRP), Edmonton, Canada.

出版信息

Am J Transplant. 2017 Apr;17(4):1071-1080. doi: 10.1111/ajt.14049. Epub 2016 Dec 9.

Abstract

After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3-22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies.

摘要

经过广泛试验,英国首次进行的临床常温机器灌注(NMP)肝脏试验结果表明该方法具有可行性和明确的安全性,与标准静态冷藏(SCS)相比,肝功能有所改善。我们展示了在北美单中心使用相同NMP技术的初步经验。获取了10个供体肝脏移植物,其中4个(40%)来自循环死亡后捐赠(DCD),9个进行了移植。有1个肝脏因门静脉插管技术故障未进行移植而被丢弃。移植的NMP移植物与移植的SCS肝脏按1:3匹配。NMP的中位时间为11.5小时(范围3.3 - 22.5小时),1个DCD肝脏灌注了22.5小时。所有移植肝脏均发挥功能,NMP受者的血清转氨酶、胆红素、国际标准化比值和乳酸水平与对照组相似得到纠正。在意向性治疗基础上,两组间30天的移植物存活率(主要结局)无统计学差异(p = 0.25)。NMP组的重症监护和住院时间显著延长。这一初步经验证明了在北美环境下NMP的可行性以及潜在技术风险,并强调需要进行更大规模的随机研究。

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