Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Study Details
Study Description
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:
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Whole liver graft or partial liver (split) from a deceased donor
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Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
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Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
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Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
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Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liver Transplantation
|
Procedure: Liver Transplantation
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [5 years]
Secondary Outcome Measures
- Disease-Free Survival [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
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Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
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No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
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No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
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Good performance status Eastern Cooperative Oncology Group 0 or 1
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Neutrophils > 1.000
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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
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Carcino-Embryonic Antigen < 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
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Written informed consent
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No other contraindications to liver transplantation
Exclusion Criteria:
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Presence of other malignancies
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Local recurrence of primary tumor
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Extra-hepatic metastatic disease
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Patients who did not receive any neoadjuvant or adjuvant therapy
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Palliative resection of primary tumor
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Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Azienda Ospedaliero - Universitaria di Bologna | Bologna | Italy | 40138 |
Sponsors and Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LITORALE2020