Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876052
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-04-21
Brief Title:
HOPE to Reduce Tumour Recurrence After LT In Patients With HCC
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Hypothermic Oxygenated Perfusion To Reduce Tumour Recurrence After Liver Transplantation In Patients With Hepatocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
POTERE
Brief Summary:
Hypothermic oxygenated ex-situ machine perfusion HOPE is a dynamic preservation method that has been developed to reduce the incidence and severity of ischaemia-reperfusion injury and to improve outcomes after liver transplantation Whit this study Pi and collaborators hypothesize that the application of ex-situ liver perfusion before LT in HCC recipients leads to an optimization of graft function with a decrease in ischaemia-reperfusion injury and a possible decrease in tumor cell growth This is multicentre prospective two-arm randomized controlled clinical trial that will will involve patients with HCC candidate to LT The liver grafts will be randomized in two groups to compare HOPE and static cold storage SCS preservation before transplantation For each group evaluation of clinical outcomes graft function tests histologic findings perfusate tumor characteristics and recurrence will be done
Detailed Description:
Tumor recurrence after liver transplantation LT in patients with hepatocellular carcinoma HCC is a major complication leading to decreased long-term survival of patients However the mechanisms leading to tumor emergence and growth remain incompletely understood Several factors can promote cancer growth or recurrence Ischemia-reperfusion injury IRI has been recognized as an important early driver of microvascular dysfunction resulting in tissue hypoxia and inflammation which promotes tumor cell growth
A recent therapeutic strategy used to reduce the incidence and severity of IRI and to improve outcomes after transplantation is ex vivo HOPE Which allows to redirect anaerobic metabolism to aerobic metabolism under hypothermic conditions protect grafts from oxidative species-related damage improve graft function and may potentially reduce cancer recurrence after liver transplantation
A multicentre prospective two-arm randomized controlled clinical trial will be performed four Italian centres Bologna Palermo Pisa e Torino will be involved A total of 192 patients with a history of HCC or active HCC already present or about to be placed in the liver transplantation waiting list of the four transplantation center will be enroll The liver grafts will be randomized in two groups to compare HOPE and SCS preservation before transplantation For each group evaluation of clinical outcomes graft function tests histologic findings perfusate tumor characteristics and recurrence will be done during follow up visit 1-3-6 and 12 months after transplantation
Livers assigned to HOPE group will be perfused by machine perfusion with cold Belzer solution 4-10C and with continuous oxygenation partial pressure of oxygen 500-600 mmHg Organs will be perfused from the start of the back-table procedure until implantation without increasing cold ischemia time CIT
In the control group livers undergoing SCS will be steeped in cold Celsior or Belzer solutions and stored in ice Presence of bacterial andor fungal contamination will be tested by setting up microbiological cultures from the preservation fluid before and after treatment in both groups
A recent therapeutic strategy used to reduce the incidence and severity of IRI and to improve outcomes after transplantation is ex vivo HOPE Which allows to redirect anaerobic metabolism to aerobic metabolism under hypothermic conditions protect grafts from oxidative species-related damage improve graft function and may potentially reduce cancer recurrence after liver transplantation
A multicentre prospective two-arm randomized controlled clinical trial will be performed four Italian centres Bologna Palermo Pisa e Torino will be involved A total of 192 patients with a history of HCC or active HCC already present or about to be placed in the liver transplantation waiting list of the four transplantation center will be enroll The liver grafts will be randomized in two groups to compare HOPE and SCS preservation before transplantation For each group evaluation of clinical outcomes graft function tests histologic findings perfusate tumor characteristics and recurrence will be done during follow up visit 1-3-6 and 12 months after transplantation
Livers assigned to HOPE group will be perfused by machine perfusion with cold Belzer solution 4-10C and with continuous oxygenation partial pressure of oxygen 500-600 mmHg Organs will be perfused from the start of the back-table procedure until implantation without increasing cold ischemia time CIT
In the control group livers undergoing SCS will be steeped in cold Celsior or Belzer solutions and stored in ice Presence of bacterial andor fungal contamination will be tested by setting up microbiological cultures from the preservation fluid before and after treatment in both groups
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