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

• Applicant: Professor Dr. Gerd Otto
• Subject Area: General and Visceral Surgery
• Term: from 2008 to 2013
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 44356531

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.

• DFG Programme: Clinical Trials
• Participating Persons: Dr. Michael Heise; Dr. Kai Kronfeld; Dr. Jochem König; Dr. Undine Samuel