Status:
RECRUITING
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Perihilar Cholangiocarcinoma
Klatskin Tumor
Eligibility:
All Genders
18-70 years
Brief Summary
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cho...
Detailed Description
Patients with unresectable pCCA who fit within inclusion criteria will be enrolled in the study. They will undergo staging laparoscopy with nodal sampling at the hepatic hilum. In case of negative sta...
Eligibility Criteria
Inclusion
- Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
- 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
- Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
- Age between 18 years and 70 years
- Absence of intra- and extrahepatic metastases
- Absence of lymph-nodal metastases at any site
- Biliary stenting of all liver districts
- No contraindications to liver transplantation
- No concomitant malignancies or history of other malignancies in the previous 5 years
- Written informed consent
Exclusion
- Intrahepatic cholangiocarcinoma
- Uncontrolled infection
- Concomitant malignancies or history of other malignancies in the previous 5 years
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06986486
Start Date
June 1 2025
End Date
January 1 2030
Last Update
May 23 2025
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Michigan, Italy, 20133