Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-73
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Presence of other malignancies

Local recurrence of primary tumor

Extra-hepatic metastatic disease

Patients who did not receive any neoadjuvant or adjuvant therapy

Trial design

Treatments tested in this trial

  • Liver Transplantation

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
IRCCS Azienda Ospedaliero - Universitaria di Bologna40138, Bologna Italy

Sponsors and collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor