Abstract
BACKGROUND: Colorectal cancer is the third most common malignancy worldwide. The occurrence of liver metastases worsens the prognosis of the patient significantly if the tumor burden is not resectable. Liver transplantation might be an option for otherwise irresectable colorectal liver metastases. In this study, we evaluate the role of two-stage hepatectomy in combination with a left-lateral living donor liver transplantation. METHODS: Patients with irresectable liver metastases having a stable disease or tumor regression after at least 8 weeks of systemic chemotherapy without an extrahepatic tumor burden (except resectable lung metastases) are suitable for study inclusion. A randomization is not planned since the control arm (systemic chemotherapy) is well established and the superiority of the transplantation procedure has to be expected. The surgical treatment consists of two steps: in a first operation, a left hemihepatectomy in the recipient will be performed. At this place, the left lateral liver lobe (segments II and III) of a living donor will be transplanted. To induce a growth of the graft, a portal vein ligation will be performed. Approximately after 2 weeks, the removal of the right hemiliver will be conducted if the control imaging shows a sufficient growth of the graft. RESULTS: The patient recruitment is ongoing. In total, three patients have been already transplanted with this protocol. Up to now, they are tumor-free and in good clinical health. DISCUSSION: With the design of the LIVER-T(W)O-HEAL study, it might be possible to offer patients with otherwise irresectable colorectal liver metastases a curative treatment option. The key point of this study will be, most probably, the patient's selection. TRIAL REGISTRATION: Registered at Clinical Trials; NCT03488953 ; registered on April 5, 2018.