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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
Italy
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
RECRUITING
Padua
Contact Information
Primary
Umberto Cillo, MD
cillo@unipd.it
049.8212211-1897
Backup
Sara Lonardi, MD
sara.lonardi@iov.veneto.it
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 18
Treatments
Experimental: Liver transplantation
Auxiliary liver transplantation and staged hepatectomy
Sponsors
Leads: Azienda Ospedaliera di Padova
Collaborators: Istituto Oncologico Veneto IRCCS

This content was sourced from clinicaltrials.gov