Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 73
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero - Universitaria di Bologna
RECRUITING
Bologna
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2030-03-30
Participants
Target number of participants: 20
Treatments
Experimental: Liver Transplantation
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov

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