Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Study Overview
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Brief Summary
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RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.

Official Title
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Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma

Conditions
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Liver Metastases

Intervention / Treatment
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* Procedure: Liver transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 and <70 years Performance status, ECOG 0-1 Histologically proved adenocarcinoma in colon or rectum BRAF wild-type CRC on primary tumor or liver metastases High standard oncological surgical resection of the primary tumor Liver metastases not eligible for curative liver resection confirmed by the validation committee At least one line (3 months) of chemotherapy At least 6 months time span from CRC resection and date of being listed on the transplantation list. At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy. Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3 CEA stable or in decrease Signed informed consent and expected cooperation of the patients for the treatment and follow up Exclusion Criteria: Weight loss >10% the last 6 months Patient BMI > 30 Participation refusal General contraindication to LT Other malignancies in the previous 5 years Pregnancy or breast feeding Any reason why, in the opinion of the investigator, the patient should not participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver transplantation<br>Auxiliary liver transplantation and staged hepatectomy | Procedure: Liver transplantation<br>* Auxiliary liver transplantation and staged hepatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation |  | within 4 weeks from liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to treat survival after liver transplantation |  | 3 and 5 years | 
| Progression free survival |  | 3 and 5 years | 
| Proportion of drop out |  | within liver transplant | 
| Mortality |  | 90 days from second stage hepatectomy | 
| Complication rate |  | 90 days after liver transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Liver Metastases, Auxiliary Liver Transplant