Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial.
Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial.
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DOI：
10.1136/bmjopen-2017-017733
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发表时间：
2017-11-28
期刊：
影响因子：
2.9
通讯作者：
Mirza DF
中科院分区：
文献类型：
--
作者：
Laing RW;Mergental H;Yap C;Kirkham A;Whilku M;Barton D;Curbishley S;Boteon YL;Neil DA;Hübscher SG;Perera MTPR;Muiesan P;Isaac J;Roberts KJ;Cilliers H;Afford SC;Mirza DF
边缘或扩展标准供体肝脏的使用正在增加。这些器官最初功能障碍和早期衰竭的风险更大，而且长期结果较差。因此，许多人因使用风险而被拒绝，而且中心之间的使用差异很大。肝脏异位常温机器灌注（NMP-L）可以实现器官的安全移植，这些器官符合明确的客观标准，表明其高风险状态，但目前所有英国移植中心都拒绝使用。边缘肝脏的活力测试和移植是一项开放标签、非随机、前瞻性、单臂试验，旨在确定当前未使用的供体肝脏是否可以被挽救并安全移植，并在患者生存方面获得相同的结果。获得的被拒绝的肝脏必须符合客观地表明其边缘状况的预定标准。经过一段时间的静态冷藏后，肝脏会受到 NMP-L 的影响。灌注开始后 4 小时内乳酸代谢≤2.5mmol/L，并结合以下两个或多个参数（胆汁产生、葡萄糖代谢、肝动脉流速≥150mL/min 和门静脉流速≥500mL/min、pH ≥7.30 和/或保持均匀灌注）将被认为是可行的并移植到合适的同意接受者体内。共同主要结果指标是 NMP-L 产生可移植器官的成功率和患者移植后 90 天的存活率。该方案得到了国家研究伦理服务（伦敦-德威研究伦理委员会，16/LO/1056）、药品和保健产品监管机构的批准，并得到了国家卫生服务血液和移植研究、创新和新技术咨询小组的认可。该试验的结果将通过国内和国际演讲以及同行评审出版物进行传播。 NCT02740608；预结果。
The use of marginal or extended criteria donor livers is increasing. These organs carry a greater risk of initial dysfunction and early failure, as well as inferior long-term outcomes. As such, many are rejected due to a perceived risk of use and use varies widely between centres. Ex situ normothermic machine perfusion of the liver (NMP-L) may enable the safe transplantation of organs that meet defined objective criteria denoting their high-risk status and are currently being declined for use by all the UK transplant centres. Viability testing and transplantation of marginal livers is an open-label, non-randomised, prospective, single-arm trial designed to determine whether currently unused donor livers can be salvaged and safely transplanted with equivalent outcomes in terms of patient survival. The procured rejected livers must meet predefined criteria that objectively denote their marginal condition. The liver is subjected to NMP-L following a period of static cold storage. Organs metabolising lactate to ≤2.5 mmol/L within 4 hours of the perfusion commencing in combination with two or more of the following parameters—bile production, metabolism of glucose, a hepatic arterial flow rate ≥150 mL/min and a portal venous flow rate ≥500 mL/min, a pH ≥7.30 and/or maintain a homogeneous perfusion—will be considered viable and transplanted into a suitable consented recipient. The coprimary outcome measures are the success rate of NMP-L to produce a transplantable organ and 90-day patient post-transplant survival. The protocol was approved by the National Research Ethics Service (London—Dulwich Research Ethics Committee, 16/LO/1056), the Medicines and Healthcare Products Regulatory Agency and is endorsed by the National Health Service Blood and Transplant Research, Innovation and Novel Technologies Advisory Group. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications. NCT02740608; Pre-results.
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影响因子：
4.6
作者：
Henry, Scot D.;van der Wegen, Pascal;van der Laan, Luc J. W.
通讯作者：
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影响因子：
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通讯作者：
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