[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Angiodynamics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Other: Use of NanoKnife System for ablation of HCC lesions","EXPERIMENTAL",null,[13],"Device: Irreversible Electroporation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Irreversible Electroporation","Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating \"nanopores\" which leads to cell destabilisation and cell death.\n\nIRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.",[9],[21],"nanoknife",[23],{"name":24,"affiliation":25,"role":26},"Ajith Siriwardena, MD FRCS","Manchester Royal Infirmiary","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Mitchell Vanderpoll","CONTACT","+44 7790921819","mvanderpoll@angiodynamics.com",[34],{"facility":25,"status":11,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Manchester","M13 9WL","United Kingdom","UK",{"type":40,"coordinates":41},"Point",[42,43],-2.23743,53.48095,{"lat":43,"lon":42},[46],{"name":24,"role":30,"phone":47,"phoneExt":11,"email":48},"+44","ajith.siriwardena@mft.nhs.uk",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607759","international-study-on-treatment-of-liver-hcc-patients-with-ire-100607759",false,"NCT07192731","International Study on Treatment of Liver (HCC) Patients With IRE","Treatment of LIVER-limited HepatoCellular Carcinoma (HCC) in Patients With Preserved Liver Function by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study","LIVERHCC-IRE","Inclusion Criteria:\n\n* Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.\n* Child-Pugh A up to A6.\n* Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.\n* Rockwood Frailty Score ≤ 3.\n* Serum bilirubin \\\u003C 30 µmol\u002FL.\n* Serum creatinine \\\u003C 150 µmol\u002FL.\n* No extrahepatic metastases\n* IRE can be used for up to 3 tumours \\\u003C 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.\n\nExclusion Criteria:\n\nGeneral:\n\n* Patients involved in other research studies.\n* Patients under the age of 18 years.\n* Inability to give informed consent.\n* Patients who are pregnant.\n* Child-Pugh B or C.\n* Patients with an ECOG status of \\> 2 at time of recruitment.\n* Rockwood Frailty Score \\> 3\n* Impaired renal function (serum creatinine \\> 150 µmol\u002FL)\n* Accepted exclusions to IRE from consensus criteria including:\n* Platelet count \\\u003C 50x109 U\u002FL.\n* International normalised ratio (INR) for blood clotting \\> 1.7.\n* Prior hepatic tumour ablation.\n\nCardiovascular fitness related exclusions:\n\n* History of ventricular arrhythmia.\n* Implanted pacemaker or defibrillator.\n* Congestive cardiac failure NYHA Class ≥ 3.\n\nTumour-related exclusions:\n\n* Tumour ≥ 3 cm in size.\n* Extrahepatic metastatic disease.\n* Jaundice (serum bilirubin \\> 30 µmol\u002FL).\n* MDT recommends use of thermal ablation for any given lesion.","ALL","18 Years",{"count":62,"type":63},50,"ESTIMATED","INTERVENTIONAL",[66],"NA","Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation",[69,70,71],"Hepatocellular Carcinoma (HCC)","Liver Ablation","Liver Cancer, Adult",[73,74,21,75],"irreversible electroporation","liver ablation","liver ire registry","NOT_YET_RECRUITING","2025-10-08",{"date":79,"type":80},"2025-10-10","ACTUAL",{"date":82,"type":63},"2026-02",{"date":84,"type":63},"2029-02",{"name":5,"class":6},1]