Hepatectomy Clinical Trials

Clinical trials related to Hepatectomy Procedure

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
Padova
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