RecruitingNot ApplicableNCT06125769

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

Sponsor

Azienda Sanitaria Ospedaliera

Enrollment

50 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Perihilar Cholangiocarcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial (LITALHICA) is studying liver transplantation as a treatment for people with a specific type of bile duct cancer near the liver (called perihilar cholangiocarcinoma) that cannot be surgically removed. **You may be eligible if:** - You have a confirmed diagnosis of perihilar cholangiocarcinoma (a tumor near the liver's bile ducts) - Your tumor is above the cystic duct and cannot be completely removed surgically, or it arose in the context of primary sclerosing cholangitis (PSC) - The tumor is smaller than 3 cm - There is no spread to nearby lymph nodes or other organs - You have been on standard chemotherapy for at least 6 months with stable or improving disease - At least 6 months have passed since your diagnosis **You may NOT be eligible if:** - You have an uncontrollable infection - You have had prior radiation, chemotherapy, or attempted surgical removal - Your tumor is larger than 3 cm - Cancer has spread inside or outside the liver - You had a biopsy done through the skin (which can spread cancer cells) - You had another cancer in the past 5 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELiver transplantation

Patients 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.