Liver Metastases
Conditions
Keywords
Colorectal Liver Metastases, Auxiliary Liver Transplant
Brief summary
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.
Interventions
PROCEDURELiver transplantation
Auxiliary liver transplantation and staged hepatectomy
Sponsors
Istituto Oncologico Veneto IRCCS
Azienda Ospedaliera di Padova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation | within 4 weeks from liver transplantation | Rate of second stage hepatectomy performed within 4 weeks from transplatation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intention to treat survival after liver transplantation | 3 and 5 years | Time from transplantation to either death or censoring |
| Progression free survival | 3 and 5 years | Time from enrolement to either progression or censoring |
| Proportion of drop out | within 100 days from listing | Rate of drop out from listing |
| Mortality | within 90 days from second stage hepatectomy | Rate of death within 90 days after second stage hepatectomy |
| Complication rate | within 90 days after liver transplant | Complications according to Dindo Clavien Classification |
Countries
Italy
Contacts
Primary ContactUmberto Cillo, MD
Backup ContactSara Lonardi, MD
Outcome results
None listed