Liver transplantation for colorectal liver metastases: What do we need to know?
Pål-Dag Line, Luis I Ruffolo, Christian Toso...
https://pubmed.ncbi.nlm.nih.gov/32305529/Actively Recruiting
Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2025-09-25
25
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are evaluating the use of liver transplantation, including living donor liver transplant LDLT, partial graft, or whole graft from deceased donors, for patients with unresectable colorectal liver metastases CRLM. The study aims to assess overall and disease-free survival over five years, as well as secondary outcomes such as graft survival and donor safety and quality of life. Donor selection follows established institutional and national protocols. Participants who meet the criteria for unresectable CRLM will undergo screening and a waiting period during which they continue chemotherapy and have regular blood tests and imaging scans every 8 weeks. Donors are also screened according to institutional protocols. After informed consent, patients receive LDLT or liver graft transplantation. Post-transplant, patients and donors are followed up routinely, with tumor and graft status reassessed every 4 months for the first 3 years, then every 6 months thereafter. During the study, participants will have clinical assessments, blood tests including tumor markers, CT and PET scans, and ongoing monitoring of their health status. Donor outcomes and quality of life are also tracked. The total follow-up period extends to 5 years post-transplant, allowing researchers to evaluate long-term survival and safety outcomes comprehensively.
CONDITIONS
LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
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Azienda Ospedaliero-Universitaria di Modena
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening of patients with liver-limited colorectal cancer metastases will include clinical assessment and imaging every 8 weeks during pre-transplant waiting phase.
Duration - Until liver transplantation and immediate recovery
Participants undergo living donor liver transplantation (LDLT) or other liver transplant procedures as part of the trial intervention.
Visits as per transplant and immediate post-operative care schedules
Duration - At least 5 years post-transplant
Participants will be monitored after transplant with standard institutional follow-up to assess patient and graft condition as well as tumor status.
Visits every 4 months for the first 3 years, then every 6 months thereafter
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor