Prospective randomised multicentre trial investigating liver preservation with HTK by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing

前瞻性随机多中心试验，研究通过简单主动脉灌注与主动脉灌注加异位动脉冲洗相比，HTK 保肝的效果

• 批准号: 44356531
• 负责人: Professor Dr. Gerd Otto
• 金额: --
• 依托单位: Interdisziplinäres Zentrum Klinische Studien (IZKS)
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2008
• 资助国家: 德国
• 起止时间: 2007-12-31 至 2012-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/44356531?language=en
• 关键词: Prospective; randomised; multicentre; trial; investigating

Ischemic type biliary lesions (ITBL) are non-ischemic and non immunogenic lesions of the bile ducts of a liver graft occurring in up to 20% of the patients after liver transplantation (LT). This damage leads to considerable morbidity including re-transplantation after LT. According to retrospective analyses, ischemic type biliary lesions after LT seem to be avoidable by additional arterial back table perfusion of the liver graft after retrieval. According to this observation, a randomized study was designed. Transplants were randomized in two groups: One group only with in situ perfusion (as usually performed) and one group with additional arterial ex situ flushing. For this study an adaptive design was used. The main outcome measure was ITBL at month 6 after LT as demonstrated by endoscopic retrograde cholangiography (ERC) or magnetic resonance cholangiography (MRC). ITBL were assumed to occur in 20% (control group) versus 5% (study group). Assessment of the imaging, blinded for patients and study groups, was performed by two radiologists and two surgeons. So far there were no reports about differences in risk potential for the recipient between the different ways of perfusion concerning life threatening events.

缺血型胆道病变（ITBL）是指肝移植术后20%的患者发生的非缺血性和非免疫原性的肝移植胆管病变。这种损害导致相当大的发病率，包括LT后再次移植。根据回顾性分析，LT后缺血型胆道病变似乎是可以避免的额外动脉回表灌注肝移植后检索。根据这一观察结果，设计了一项随机研究。移植被随机分为两组：一组仅进行原位灌注（如通常进行的），一组进行额外的动脉异位冲洗。本研究采用自适应设计。主要结果指标是肝移植后6个月时的ITBL，如内镜逆行胆管造影（ERC）或磁共振胆管造影（MRC）所示。假设ITBL发生率为20%（对照组）与5%（研究组）。由两名放射科医生和两名外科医生对患者和研究组进行盲态成像评估。到目前为止，还没有关于不同灌注方式之间受者在危及生命事件方面的潜在风险差异的报告。