LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 > 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)
Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
No extrahepatic metastatic disease
Uncontrollable infection
Prior radiotherapy or chemotherapy
Prior biliary surgical resection or attempted surgical resection
Diameter of tumor >3cm
Azienda Sanitaria Ospedaliera
Lead sponsor
Istituto Oncologico Veneto IRCCS
Collaborator