LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

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.

Inclusion Criteria:

• 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
• Radial tumor diameter ≤3 cm
• At least six months between first diagnosis of pCCA and date of inclusion
• At least six months of SOC chemotherapy, achieving disease stability or partial response

Exclusion Criteria:

• Uncontrollable infection
• Prior radiotherapy or chemotherapy
• Prior biliary surgical resection or attempted surgical resection
• Diameter of tumor >3cm
• Presence of intra-hepatic metastases or iCCA
• Present or past evidence of extrahepatic metastatic disease
• Transperitoneal biopsy (including percutaneous ecography-guided FNA)
• Prior neoplasms, except those treated curatively for more than 5 years without recurrence
• Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
• Pregnant or breastfeeding women
• Medical-surgical contraindications for liver transplantation