Colorectal Cancer, Liver Metastasis Colon Cancer
Conditions
Keywords
liver transplantation, non-resectable colorectal liver metastasis
Brief summary
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
Interventions
PROCEDURELiver Transplantation
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 73 Years
Healthy volunteers
No
Inclusion criteria
* Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection * Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections * No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy * No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography * Good performance status Eastern Cooperative Oncology Group 0 or 1 * Neutrophils \> 1.000 * Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours * Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed * Written informed consent * No other contraindications to liver transplantation
Exclusion criteria
* Presence of other malignancies * Local recurrence of primary tumor * Extra-hepatic metastatic disease * Patients who did not receive any neoadjuvant or adjuvant therapy * Palliative resection of primary tumor * Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival | 5 years |
Countries
Italy
Outcome results
None listed