Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Last updated: April 22, 2024
Sponsor: Azienda Ospedaliera di Padova
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Metastases

Neoplasm Metastasis

Liver Cancer

Treatment

Liver transplantation

Clinical Study ID

NCT04865471
AOP1838
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 validationcommittee
  • At least one line (3 months) of chemotherapy
  • At least 6 months time span from CRC resection and date of being listed on thetransplantation list.
  • At least 8 weeks of tumor control: stable disease or partial response according toRECIST 1.1 criteria
  • No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CTexcept patients may have <3 lung lesions all<15mm resected or treated by radiotherapyor metastatic hilar nodes treated by resection and without recurrence at 3 months fromresection 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 andfollow up

Exclusion

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 Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Liver transplantation
Phase:
Study Start date:
October 01, 2020
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Active - Recruiting

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