[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607668":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":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Angiodynamics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Use of NanoKnife System for ablation of metastatic colorectal 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","100607668","international-study-on-treatment-of-patients-with-metastatic-colorectal-liver-lesions-patients-with-ire-100607668",false,"NCT07191548","International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE","Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.","LIVERMET-IRE","Inclusion Criteria:\n\n* Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.\n* Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.\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* Up to two lung metastases (\\\u003C 2cm in size permitted at enrolment).\n* Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.\n* Primary rectal tumour can remain in situ treated with radiotherapy\u002Fchemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.\n* No prior hepatic tumour ablation\n\nExclusion Criteria:\n\n* Patients involved in other research studies.\n* Inability to give informed consent.\n* Patients who are pregnant.\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 ≥ 4 cm in size.\n* Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, \\> 2 lung metastases, all segment involvement multiple liver metastases.\n* Jaundice (serum bilirubin \\> 30 µmol\u002FL).\n* MDT\u002Ftumour recommends use of thermal ablation instead of IRE 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 metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.",[69,70,71],"Colorectal Adenocarcinoma Metastatic in the Liver","Liver Ablation","Liver Cancer, Adult",[73,74,75,21,76],"irreversible electroporation","liver ablation","metastatic liver disease","liver ire registry","NOT_YET_RECRUITING","2025-10-08",{"date":80,"type":81},"2025-10-10","ACTUAL",{"date":83,"type":63},"2026-02",{"date":85,"type":63},"2029-02",{"name":5,"class":6},1]