Living Donor Liver Transplantation for Neoadjuvant-Treated, Unresectable Intrahepatic Cholangiocarcinoma (LIVINCA): Study Protocol for a One-Armed, Monocentric, Non-Randomized Trial.

Introduction: 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 aimed 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 radiotherapy 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. 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.