Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease

Abstract

During conventional liver transplantation (CLT), ischemia-reperfusion injury (IRI) is inevitable and associated with complications such as early allograft dysfunction (EAD), primary non-function, and ischemic-type biliary lesions. We’ve established a novel procedure called ischemia-free liver transplantation (IFLT). The results from the pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes in comparison to CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT. This is an investigator initiated, open-label, phase-III, prospective, single-center randomized, controlled trial on the effects of IFLT in patients with end-stage liver disease.Adult patients eligible for liver transplantation are screened for participating in this trial and will be randomized between IFLT group (n=34) and CLT group (n=34). After 12-month follow-up of the last enrolled recipient, the outcomes will be analyzed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.