[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525748":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":83,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":20,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Azienda Sanitaria Ospedaliera","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study population","EXPERIMENTAL","Candidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI\u002FCT).\n\nPatients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease.\n\nFollowing completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.",[13],"Procedure: Liver transplantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Liver transplantation","Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery\u002Fceliac axis.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Enrico Gringeri, Prof.","Azienda Ospedale Università di Padova","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+39 0498218547","enrico.gringeri@unipd.it",[32],{"facility":24,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Padova","PADOVA","35128","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],11.14261,44.38225,{"lat":43,"lon":42},[46,47,48,51,53,55,57,59,61,63,65,67,69,71,73,75,77,79,81],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":49,"role":50,"phone":20,"phoneExt":20,"email":20},"Umberto Cillo, Prof.","SUB_INVESTIGATOR",{"name":52,"role":50,"phone":20,"phoneExt":20,"email":20},"Jacopo Lanari, Dr.",{"name":54,"role":50,"phone":20,"phoneExt":20,"email":20},"Domenico Bassi, Dr.",{"name":56,"role":50,"phone":20,"phoneExt":20,"email":20},"Alessandra Bertacco, Dr.",{"name":58,"role":50,"phone":20,"phoneExt":20,"email":20},"Riccardo Boetto, Dr.",{"name":60,"role":50,"phone":20,"phoneExt":20,"email":20},"Francesco Enrico D'Amico, Prof",{"name":62,"role":50,"phone":20,"phoneExt":20,"email":20},"Annalisa Dolcet, Dr.",{"name":64,"role":50,"phone":20,"phoneExt":20,"email":20},"Alessandro Vitale, Prof.",{"name":66,"role":50,"phone":20,"phoneExt":20,"email":20},"Alessandro Furlanetto, Dr.",{"name":68,"role":50,"phone":20,"phoneExt":20,"email":20},"Sara Lonardi, Dr.",{"name":70,"role":50,"phone":20,"phoneExt":20,"email":20},"Francesca Bergamo, Dr.",{"name":72,"role":50,"phone":20,"phoneExt":20,"email":20},"Caterina Solda', Dr.",{"name":74,"role":50,"phone":20,"phoneExt":20,"email":20},"Mario Domenico Rizzato, Dr.",{"name":76,"role":50,"phone":20,"phoneExt":20,"email":20},"Martina Gambato, Dr.",{"name":78,"role":50,"phone":20,"phoneExt":20,"email":20},"Francesco Ferrara, Dr.",{"name":80,"role":50,"phone":20,"phoneExt":20,"email":20},"Marco Krengli, Prof.",{"name":82,"role":50,"phone":20,"phoneExt":20,"email":20},"Sara Galuppo, Dr.",{"type":25,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Enrico Gringeri","Associate Professor",[87],{"name":88,"class":6},"Istituto Oncologico Veneto IRCCS","100525748","liver-transplantation-for-non-resectable-peri-hilar-cholangiocarcinoma-litalhica-100525748",false,"NCT06125769","LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)","LITALHICA","Inclusion Criteria:\n\n* Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 \\> 100 mg\u002FmL and\u002For a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)\n* Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC\n* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes\n* No extrahepatic metastatic disease\n* Radial tumor diameter ≤3 cm\n* At least six months between first diagnosis of pCCA and date of inclusion\n* At least six months of SOC chemotherapy, achieving disease stability or partial response\n\nExclusion Criteria:\n\n* Uncontrollable infection\n* Prior radiotherapy or chemotherapy\n* Prior biliary surgical resection or attempted surgical resection\n* Diameter of tumor \\>3cm\n* Presence of intra-hepatic metastases or iCCA\n* Present or past evidence of extrahepatic metastatic disease\n* Transperitoneal biopsy (including percutaneous ecography-guided FNA)\n* Prior neoplasms, except those treated curatively for more than 5 years without recurrence\n* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study\n* Pregnant or breastfeeding women\n* Medical-surgical contraindications for liver transplantation","ALL","18 Years","70 Years",{"count":100,"type":101},50,"ESTIMATED","INTERVENTIONAL",[104],"NA","LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.",[107],"Perihilar Cholangiocarcinoma",[17],"2026-03-30",{"date":111,"type":112},"2026-04-03","ACTUAL",{"date":114,"type":112},"2024-01-15",{"date":116,"type":101},"2033-11-01",{"name":5,"class":6},1]