[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-transplantation-lt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-transplantation-lt":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644712","new-biomarkers-for-organ-viability-assessment-during-hypothermic-machine-perfusion-in-liver-transplantation-the-role-of-extemporaneous-histological-examination-100644712",false,"NCT07674394","New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.","LOVE","Inclusion Criteria:\n\n1. Adult liver transplant recipients (≥18 years of age).\n2. Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).\n3. Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.\n4. Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.\n5. Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.\n6. Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes.\n\nExclusion Criteria:\n\n1. Inadequate or fragmented biopsy samples, preventing proper histological evaluation.\n2. Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).\n3. Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.\n4. Organs undergoing experimental or non-standard perfusion protocols.\n5. Grafts from donors \\\u003C18 years of age.\n6. Recipient refusal or inability to provide informed consent.\n7. Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies).\n8. Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.\n\nThe purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.\n\nThe main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.\n\nA total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.\n\nThe results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.",[26,27,28,29],"Liver Transplantation (LT)","Early Allograft Dysfunction","Primary Non-function","Ischemia-Reperfusion Injury",[31,32,33,29,34],"liver transplantation","Early Allograft Dysfunction (EAD)","Primary Non-Function (PNF)","Liver Graft Viability Assessment","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":20},"2026-07",{"date":43,"type":20},"2029-06",{"name":45,"class":46},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","OTHER",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100640838","liver-transplant-for-hepatocellular-carcinoma-100640838","NCT07629193","Liver Transplant for Hepatocellular Carcinoma","TH-CHC","Inclusion Criteria\n\n1. Adults (≥18 years).\n2. Underwent LT for HCC between January 1, 2018 and December 31, 2023.\n\nExclusion Criteria\n\n1. No evidence of HCC (imaging or histology).\n2. LT performed for another intrahepatic tumor other than HCC.\n3. The patient's objection to the use of their data.",{"count":56,"type":20},562,"OBSERVATIONAL","This research focuses on analysing data collected as part of your usual care. Currently, the eligibility of patients with hepatocellular carcinoma for liver transplantation is based on the calculation of scores. These scores mainly take into account the volume of the tumour measured by imaging, one or more blood markers and the patient's general condition.\n\nHowever, these scores do not take into account:\n\n* the concept of downstaging (i.e. the prior reduction of tumour volume through locoregional or systemic treatments, which subsequently allows access to LT), which is becoming increasingly widespread\n* the dynamics of hepatocellular carcinoma (tumour recurrence while waiting on the transplant list, administration of wait-and-see treatments)\n* certain anatomopathological parameters (such as the macro-trabecular subtype of HCC).\n\nThe aim of our study is to develop a new score incorporating these factors in order to identify patients with hepatocellular carcinoma who could truly benefit from a liver transplant.\n\nTo answer the question posed in the research, data will be collected from 402 people who received a liver transplant for hepatocellular carcinoma at three hospitals in the Paris region between 1 January 2018 and 31 December 2023, and from 160 people at two international hospitals in Canada and Belgium.",[60,26],"Hepatocellular Carcinoma (HCC)",[62,26],"predictive score","2026-06-01",{"date":65,"type":39},"2026-06-05",{"date":67,"type":20},"2026-06",{"date":69,"type":20},"2027-01",{"name":71,"class":46},"Assistance Publique - Hôpitaux de Paris"]