[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453492":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":39,"collaborators":11,"id":41,"slug":11,"hasResults":42,"nctId":43,"briefTitle":17,"officialTitle":17,"acronym":11,"eligibilityCriteria":44,"healthyVolunteers":42,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":11,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liver Transplantation","EXPERIMENTAL",null,[13],"Procedure: Liver Transplantation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"PROCEDURE","Liver Transplantation for Non-Resectable Colorectal Liver Metastasis",[9],[20],{"facility":21,"status":22,"city":23,"state":11,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"IRCCS Azienda Ospedaliero - Universitaria di Bologna","RECRUITING","Bologna","40138","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],11.33875,44.49381,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Matteo Cescon, M.D.","CONTACT","+390512144785","matteo.cescon@unibo.it",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100453492",false,"NCT05185245","Inclusion Criteria:\n\n* Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection\n* Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections\n* No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy\n* No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography\n* Good performance status Eastern Cooperative Oncology Group 0 or 1\n* Neutrophils \\> 1.000\n* Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours\n* Carcino-Embryonic Antigen \\\u003C 80 µg\u002FL or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed\n* Written informed consent\n* No other contraindications to liver transplantation\n\nExclusion Criteria:\n\n* Presence of other malignancies\n* Local recurrence of primary tumor\n* Extra-hepatic metastatic disease\n* Patients who did not receive any neoadjuvant or adjuvant therapy\n* Palliative resection of primary tumor\n* Any other reason, according to the investigators, that could be a contraindication to protocol enrollment","ALL","18 Years","73 Years",{"count":49,"type":50},20,"ESTIMATED","INTERVENTIONAL",[53],"NA","The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.\n\nPatients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.\n\nType of different transplantations proposed are as follows:\n\n1. Whole liver graft or partial liver (split) from a deceased donor\n2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.\n3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.\n4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.\n5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.\n6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.\n\nIn cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome",[56,57],"Liver Metastasis Colon Cancer","Colorectal Cancer",[59,60],"liver transplantation","non-resectable colorectal liver metastasis","2022-01-07",{"date":63,"type":64},"2022-01-11","ACTUAL",{"date":66,"type":64},"2021-04-01",{"date":68,"type":50},"2030-03-30",{"name":5,"class":6},1]