Division of Organ Transplantation, Department of Surgery, University of Massachusetts Memorial Hospital, University of Massachusetts, Worcester, MA.
Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI.
Transplantation. 2021 Apr 1;105(4):796-815. doi: 10.1097/TP.0000000000003573.
Recent trials in liver machine perfusion (MP) have revealed unique challenges beyond those seen in most clinical studies. Correct trial design and interpretation of data are essential to avoid drawing conclusions that may compromise patient safety and increase costs.
The International Liver Transplantation Society, through the Special Interest Group "DCD, Preservation and Machine Perfusion," established a working group to write consensus statements and guidelines on how future clinical trials in liver perfusion should be designed, with particular focus on relevant clinical endpoints and how different techniques of liver perfusion should be compared. Protocols, abstracts, and full published papers of clinical trials using liver MP were reviewed. The use of a simplified Grading of Recommendations Assessment, Development, and Evaluation working group (GRADE) system was attempted to assess the level of evidence. The working group presented its conclusions at the International Liver Transplantation Society consensus conference "DCD, Liver Preservation, and Machine Perfusion" held in Venice, Italy, on January 31, 2020.
Twelve recommendations were proposed with the main conclusions that clinical trials investigating the effect of MP in liver transplantation should (1) make the protocol publicly available before the start of the trial, (2) be adequately powered, and (3) carefully consider timing of randomization in function of the primary outcome.
There are issues with using accepted primary outcomes of liver transplantation trials in the context of MP trials, and no ideal endpoint could be defined by the working group. The setup of an international registry was considered vital by the working group.
最近在肝脏机械灌注（MP）的试验中发现了一些独特的挑战，这些挑战超出了大多数临床研究中所见的挑战。正确的试验设计和对数据的解释对于避免得出可能危及患者安全并增加成本的结论至关重要。
国际肝脏移植学会通过“DCD、保存和机械灌注”特别兴趣小组，成立了一个工作组，就如何设计未来的肝脏灌注临床试验撰写共识声明和指南，特别关注相关的临床终点以及如何比较不同的肝脏灌注技术。审查了使用肝脏 MP 的临床试验的方案、摘要和全文发表的论文。尝试使用简化的推荐评估、制定和评估工作组（GRADE）系统来评估证据水平。工作组于 2020 年 1 月 31 日在意大利威尼斯举行的国际肝脏移植学会共识会议“DCD、肝脏保存和机械灌注”上介绍了其结论。
提出了 12 项建议，主要结论是，研究 MP 在肝移植中作用的临床试验应（1）在试验开始前公开方案，（2）充分赋权，（3）根据主要结局仔细考虑随机分组的时间。
在 MP 试验中使用肝移植试验的公认主要结局存在问题，工作组无法定义理想的终点。工作组认为建立一个国际登记处至关重要。
