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

缺血性胆道病变（ITBL）是肝移植后胆管的非缺血性和非免疫原性病变，发生在高达20%的肝移植后患者中。这种损害导致相当大的发病率，包括肝移植后的再移植。根据回顾性分析，肝移植后的缺血型胆道病变似乎可以通过肝移植后的额外动脉背台灌注来避免。根据这一观察结果，我们设计了一项随机研究。移植物随机分为两组：一组仅进行原位灌注（通常进行），另一组进行额外的动脉非原位冲洗。本研究采用自适应设计。主要结局指标是经内镜逆行胆管造影（ERC）或磁共振胆管造影（MRC）证实的肝移植后6个月的ITBL。假设ITBL发生率为20%（对照组）和5%（研究组）。两名放射科医生和两名外科医生对患者和研究组进行了盲法成像评估。到目前为止，还没有关于不同灌注方式在危及生命事件方面对受者的潜在风险差异的报道。

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.