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Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Recruiting
18-70 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Liver Metastases

NCT04865471

Azienda Ospedaliera di Padova

3 May 2024

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