Status:
NOT_YET_RECRUITING
Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Jena University Hospital
Conditions:
Living Donor Liver Transplantation
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently ...
Detailed Description
Intrahepatic cholangiocarcinoma (iCCA) is classified among primary liver tumors and has demonstrated a consistently increasing incidence in recent years. Due to the poor long-term survival rates repor...
Eligibility Criteria
Inclusion
- non-resectable intrahepatic cholangiocarcinoma (either for localization / distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis / cirrhosis)
- biopsy proven grading G1 / G2
- in case of mixed hepatocellular carcinoma / cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 / G2
- response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory
- peritoneal carcinosis / extrahepatic spread ruled out in PET-CT and/or MRT/CT and, at latest, during exploration
- age ≥ 18
- blood-group compatible living donor available
- in female patients: negative pregnancy test
- written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)
Exclusion
- extrahepatic tumor/metastases
- G3 tumors
- progress under neoadjuvant treatment according to the RECIST-criteria
- pregnancy or breastfeeding
- patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
- general contraindications for liver transplantation
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06539377
Start Date
September 1 2024
End Date
October 1 2031
Last Update
August 6 2024
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