Huang Changjun, Huang Shanzhou, Tang Yunhua, Zhao Qiang, Wang Dongping, Ju Weiqiang, Yang Lu, Zhang Jian, Wu Linwei, Chen Maogen, Zhang Zhiheng, Zhu Zebin, Wang Linhe, Zhu Caihui, Zhang Yixi, Sun Chengjun, Xiong Wei, Shen Yuekun, Chen Xiaoxiang, Ma Yi, Hu Anbin, Zhu Xiaofeng, Rong Jian, Cai Changjie, Guo Zhiyong, He Xiaoshun
Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Guangdong Provincial Key Laboratory of Organ Donation and Transplant Immunology, Guangzhou, China.
BMJ Open. 2020 May 5;10(5):e035374. doi: 10.1136/bmjopen-2019-035374.
During conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.
This is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18-75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C-4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
The protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.
ChiCTR1900021158.
在传统肝移植（CLT）过程中，缺血再灌注损伤（IRI）不可避免，且与早期移植肝功能障碍（EAD）、原发性无功能和缺血型胆管病变等并发症相关。我们建立了一种名为无缺血肝移植（IFLT）的新方法。一项初步研究结果表明，IFLT可能预防IRI，并比CLT产生更好的移植效果。本研究的目的是进一步评估IFLT与CLT在终末期肝病患者中的疗效和安全性。
这是一项由研究者发起的、开放标签、III期、前瞻性、单中心随机对照试验，旨在研究IFLT对终末期肝病患者的影响。符合肝移植条件的成年患者（年龄18 - 75岁）将被筛选参加本试验，并随机分为IFLT组（n = 34）和CLT组（n = 34）。在IFLT组中，供肝将通过持续常温机器灌注（NMP）进行获取、保存和植入。在CLT组中，供肝将在快速冷灌注后获取，保存在0°C - 4°C溶液中，并在低温和低氧条件下植入。两组患者将按照我们中心的标准方案进行管理。主要终点是肝移植后EAD的发生率。将观察并记录供肝和受者的术中及术后参数，并评估术后肝移植肝功能、并发症以及受者和移植物的存活情况。在最后一名入组受者进行12个月的随访后，将分析结果以评估IFLT与CLT在终末期肝病患者中的安全性和疗效。
该方案已由中山大学附属第一医院伦理委员会审查并批准。研究结果将通过会议报告和同行评审的科学期刊向公众传播。
ChiCTR1900021158。
