[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534264":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":49,"locations":55,"responsibleParty":73,"collaborators":26,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria di Modena","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Machine perfusion","EXPERIMENTAL","The liver graft to be transplanted is treated with 90 minutes of D-HOPE machine perfusion",[13,14],"Device: D-HOPE machine perfusion","Procedure: Liver transplantation",{"label":16,"type":17,"description":18,"interventionNames":19},"No machine perfusion","ACTIVE_COMPARATOR","Standard liver transplantation",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","D-HOPE machine perfusion","use of the device",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Liver transplantation","Liver transplantation for HCC within Milan criteria",[9,16],[33,37,39,42,45,47],{"name":34,"affiliation":35,"role":36},"Fabrizio Di Benedetto","University of Modena and Reggio Emilia","STUDY_CHAIR",{"name":38,"affiliation":35,"role":36},"Massimo Dominici",{"name":40,"affiliation":41,"role":36},"Pietro Campiglia","University of Salerno",{"name":43,"affiliation":41,"role":44},"Eduardo M Sommella","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":35,"role":44},"Valentina Masciale",{"name":48,"affiliation":35,"role":44},"Ilenia Mastrolia",[50],{"name":51,"role":52,"phone":53,"phoneExt":26,"email":54},"Paolo Magistri, MD FACS","CONTACT","+390594225265","paolo.magistri@unimore.it",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"AOU di Modena","RECRUITING","Modena","MO","41124","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],10.92539,44.64783,{"lat":68,"lon":67},[71],{"name":51,"role":52,"phone":72,"phoneExt":26,"email":54},"+390594225178",{"type":44,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Paolo Magistri","Assistant Professor of Surgery","100534264","impact-of-graft-reconditioning-with-hypothermic-machine-perfusion-on-hcc-recurrence-after-liver-transplantation-100534264",false,"NCT06236568","Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation","Inclusion Criteria:\n\n* Patients with HCC within Milan criteria at listing candidate for liver transplantation\n* ECOG 0-2\n* DBD donors\n* capability to sign an informed consent\n\nExclusion Criteria:\n\n* pediatric patients\n* DCD donors\n* DBD extended criteria requiring machine perfusion (no ethical randomization)\n* living donor liver transplantation\n* split liver","ALL","18 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.\n\nThe 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 (1:1) 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.\n\nBlood 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).\n\nPrimary 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 2.0 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.",[92,93],"Hepatocellular Carcinoma","Liver Transplant; Complications",[95,96,97,98,9,99],"Hepatocellular carcinoma","Liver Transplantation","Metabolomics","Liquid biopsy","Ischemia reperfusion injury","2024-02-06",{"date":102,"type":103},"2024-02-07","ACTUAL",{"date":100,"type":103},{"date":106,"type":86},"2030-12-31",{"name":5,"class":6},1]