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
Single group
Liver transplantation
Procedure/SurgeryPatients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.
Overall Survival (OS)
Survival from time of transplantation to time of death or last follow up
Overall survival comparison with chemotherapy alone
Comparison of 3-year survival between patients enrolled in the LITALHICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
Progression-Free Survival (PFS)
Survival from time of transplantation to time of death or first evidence of progression of disease
Overall survival from the time of recurrence
Survival from time of recurrence to time of death or last follow up
Progression-free survival comparison with chemotherapy alone
Comparison of 3-year progression-free survival between patients enrolled in the LITALHICA study and progression-free survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
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Azienda Sanitaria Ospedaliera
Lead sponsor
Istituto Oncologico Veneto IRCCS
Collaborator
