Supplementary Material for: Living donor liver transplantation for neo-adjuvant treated, unresectable intrahepatic cholangiocarcinoma (LIVINCA): study protocol for a one-armed, mono-centric, non-randomized trial

Background Intrahepatic cholangiocarcinoma has demonstrated a consistently increasing incidence in recent years. In cases of unresectability, palliative chemotherapy often remains the only option, typically associated with a poor prognosis. Liver transplantation might be an option for otherwise unresectable intrahepatic cholangiocarcinoma. We aim to conduct a prospective, non-randomized study to further explore the effects of living-donor liver transplantation in the treatment of unresectable neoadjuvant treated intrahepatic cholangiocarcinoma. Methods Patients with unresectable intrahepatic cholangiocarcinoma having a stable disease or tumor regression after systemic chemotherapy without an extrahepatic tumor burden are suitable for study inclusion. For a local control of the tumor, an additional local-ablative therapy in means of a selective internal radio-therapy is mandatory. The main concept of the surgical procedure is a liver transplantation using the left (segments II – IV) or the right lobe (segments V – VIII) of a living donor. In oncosurgical optimal conditions, a two-staged hepatectomy combined with the (initially) auxiliary transplantation of a left-lateral lobe of a living donor is the possible. Results The patient recruitment will start in September 2024. Conclusion The design of the LIVINCA study may provide patients with otherwise unresectable intrahepatic cholangiocarcinoma a chance for a curative treatment option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients. Trial registration Registered at Clinical Trials; NCT06539377; registered on August 6, 2024.