[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557535":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":19,"responsibleParty":33,"collaborators":19,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":19,"enrollmentInfo":47,"targetDuration":19,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":19},{"fullName":5,"class":6},"Jena University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Living donor liver transplantation","EXPERIMENTAL","The evaluation tests prior the transplantation will be performed following the standard protocol for the evaluation of a waiting list applicants prior liver transplantation. The aim of this procedure is to rule out any significant co-morbidities (e.g. cardiologic diseases, other malignancies) which would preclude liver transplantation.\n\nAfter successful evaluation of the recipient and waiting list registration with Eurotransplant, the AB0-compatible donor will be evaluated as well according to a center-specific protocol.\n\nFor a local control of the tumor, an additional local-ablative therapy (SIRT) is mandatory.",[13],"Procedure: Living donor liver transplantation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"PROCEDURE","Liver transplantation from living donor donation (SII\u002FIII as left-lateral donation during a \"two stage\"-procedure or left lobe donation or right lobe donation) in patients with unresectable intrahepatic cholangiocarcinoma.",[9],null,[21,24,26],{"name":22,"affiliation":5,"role":23},"Utz Settmacher, Prof","STUDY_DIRECTOR",{"name":25,"affiliation":5,"role":23},"Falk Rauchfuss, Prof",{"name":27,"affiliation":5,"role":23},"Laura Schwenk, MD",[29],{"name":25,"role":30,"phone":31,"phoneExt":19,"email":32},"CONTACT","0049 3641 9 322695","falk.rauchfuss@med.uni-jena.de",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Falk Rauchfuß","Prof. Dr. med. Falk Rauchfuß, Sectio head liver transplantation, Principal investigator","100557535","living-donor-liver-transplantation-for-intrahepatic-cholangiocarcinoma-100557535",false,"NCT06539377","Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma","Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma","LIVINCA","Inclusion Criteria:\n\n* non-resectable intrahepatic cholangiocarcinoma (either for localization \u002F distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis \u002F cirrhosis)\n* biopsy proven grading G1 \u002F G2\n* in case of mixed hepatocellular carcinoma \u002F cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 \u002F G2\n* response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory\n* peritoneal carcinosis \u002F extrahepatic spread ruled out in PET-CT and\u002For MRT\u002FCT and, at latest, during exploration\n* age ≥ 18\n* blood-group compatible living donor available\n* in female patients: negative pregnancy test\n* written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)\n\nExclusion Criteria:\n\n* extrahepatic tumor\u002Fmetastases\n* G3 tumors\n* progress under neoadjuvant treatment according to the RECIST-criteria\n* pregnancy or breastfeeding\n* patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons\n* general contraindications for liver transplantation","ALL","18 Years",{"count":48,"type":49},6,"ESTIMATED","INTERVENTIONAL",[52],"NA","This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication \"non-resectable intrahepatic cholangiocarcinoma\" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).",[55,56,57],"Living Donor Liver Transplantation","Liver Transplantation","Neoadjuvant Therapy",[59,60,61,62],"intrahepatic cholangiocarcinoma","living donor liver transplantation","neoadjuvant therapy","SIRT","NOT_YET_RECRUITING","2024-08-01",{"date":66,"type":67},"2024-08-06","ACTUAL",{"date":69,"type":49},"2024-09-01",{"date":71,"type":49},"2031-10-01",{"name":5,"class":6}]