Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236568
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-24
Brief Title:
Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of devices for liver grafts perfusion before transplantation either hypothermic HOPE or normothermic NMP is rapidly spreading thanks to the promising results obtained so far in terms of graft survival and post-operative morbidity Besides the well-established ability to increase the rate of transplantability of extended criteria donors ECD and donors after cardiac death DCD the use of machine perfusion MP may also improve the oncological outcomes of patients affected by hepatocellular carcinoma HCC undergoing liver transplantation LT The underlying mechanism is represented by the modulation of the ischemia-reperfusion injury IRI-related cellular damage obtained by the liver graft perfusion with HOPE before LT The identification of biomarkers able to predict graft outcomes and highlight the mechanism of graft injury before transplantation rapidly and in non-invasive manner is therefore needed Mass spectrometry-based metabolomics has already shown its potential by using perfusion liquids or pre-implantation biopsies
The aim of the investigators is to run an open-label randomised controlled trial to study the impact of treating standard liver grafts from brain dead donors DBD with HOPE before liver transplant in patients affected by HCC Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria Eligible patients will be randomly assigned 11 with the use of a dedicated software to MP intervention group or no-MP control group before liver transplantation Untargeted mass spectrometry metabolomics UHPLC-HRMS will be performed on liver graft perfusate liver graft biopsy and recipient blood samples to identify by classification methods novel predictive markers of IRI Furthermore rapid targeted MS approaches will be performed on VIP metabolites and known key compounds such as TCA aminoacids energy metabolism to rapidly assess graft function as well as post-operative outcome
Blood samples of the recipient will be collected at two checkpoints listing and 3 months after liver transplant to evaluate exosomes and miRNA expression fluctuations liquid biopsy
Primary outcomes of the study will be overall survival graft survival and recurrence-free survival at 1- and 2-years Survival results will be compared to those expected based on the Metroticket 20 score to assess the impact of MP in reducing the risk of HCC recurrence Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern
The aim of the investigators is to run an open-label randomised controlled trial to study the impact of treating standard liver grafts from brain dead donors DBD with HOPE before liver transplant in patients affected by HCC Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria Eligible patients will be randomly assigned 11 with the use of a dedicated software to MP intervention group or no-MP control group before liver transplantation Untargeted mass spectrometry metabolomics UHPLC-HRMS will be performed on liver graft perfusate liver graft biopsy and recipient blood samples to identify by classification methods novel predictive markers of IRI Furthermore rapid targeted MS approaches will be performed on VIP metabolites and known key compounds such as TCA aminoacids energy metabolism to rapidly assess graft function as well as post-operative outcome
Blood samples of the recipient will be collected at two checkpoints listing and 3 months after liver transplant to evaluate exosomes and miRNA expression fluctuations liquid biopsy
Primary outcomes of the study will be overall survival graft survival and recurrence-free survival at 1- and 2-years Survival results will be compared to those expected based on the Metroticket 20 score to assess the impact of MP in reducing the risk of HCC recurrence Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None