[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391518":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":32,"overallOfficials":43,"centralContacts":116,"locations":122,"responsibleParty":141,"collaborators":11,"id":145,"slug":11,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":11,"eligibilityCriteria":149,"healthyVolunteers":146,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":156,"studyType":157,"phases":11,"briefSummary":158,"conditions":159,"keywords":11,"overallStatus":125,"whyStopped":11,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Hospital Vall d'Hebron","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival at 1, 3, and 5 years post-transplant",null,"5 years",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Recurrence free survival at 1, 3 and 5 years post-transplant",{"measure":17,"description":11,"timeFrame":12},"Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year",{"measure":19,"description":11,"timeFrame":12},"The rate of patients included in the study who are finally transplanted.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":21,"timePerspective":22,"maskingInfo":11},"COHORT","PROSPECTIVE","A prospective multicentre pilot study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases.\n\nThe number of subjects necessary is 34 patients to achieve a power of 82% with a significance level of 0.05 to detect a 40% difference between the estimated 50% survival of those patients who are transplanted and 10% of those patients with hCCA unresectable who are not transplanted. This corresponds to a hazard ratio of 3.3219. Estimated loss to follow-up of 10% of patients.\n\nRADIOLOGICAL EVALUATION\n\nIt will be considered unresectable those lesions Bismuth IV with the following criteria (Jarnagin WR, et al. Ann Surg 2001; 234:507; Memorial Sloan Kettering Cancer Center Hilar Cholangiocarcinoma Classification):\n\n* Bilateral extension to second order biliary\n* Unilateral extension to second-order biliary radicals AND contralateral portal vein involvement OR contralateral hepatic lobar atrophy\n* Main or bilateral portal vein involvement\n* Insufficient future liver remnant even after portal embolization\n\nIt will be performed the tumoral marker (CA 19.9), multiphase chest-abdomen CT scan, magnetic resonance cholangiopancreatography (MRCP) as well as positon emission tomography (PET)-scan if there is doubts of distant disease and upper endoscopic ultrasound (EUS) in order to rule out any obvious lymph node metastases. A biliary drainage will be placed by percutaneous transhepatic biliary drainage (PTBD) or endoscopic biliary drainage (EBD).\n\nNEOADJUVANT TREATMENT\n\nNeoadjuvant treatment consisting of:\n\n1. External beam radiotherapy at a total dose of 50-54 Gy, delivered in 25-27 fractions of 1.8-2 Gy per day over 5 weeks. Dose reduction may be considered if necessary, or stereotactic body radiotherapy (SBRT), to be agreed according to the center's clinical practice.\n2. Capecitabine will be given concurrently with radiotherapy at a dose of 825 mg\u002Fm² orally twice daily, seven days a week.\n3. Cisplatin 25 mg\u002Fm² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg\u002Fm² on days 1 and 8 of each 21-day cycle until the time of transplantation (minimum 4 cycles).\n\nAs an alternative, neoadjuvant treatment without radiotherapy is proposed:\n\na. Cisplatin 25 mg\u002Fm² on days 1 and 8 of each 21-day cycle + gemcitabine 1000 mg\u002Fm² on days 1 and 8 of each 21-day cycle + durvalumab 1500 mg on day 1 of each 21-day cycle for 6 cycles (18 weeks).\n\nContinue treatment for at least eight weeks without durvalumab (minimum 60-day wash-out period), while maintaining gemcitabine-cisplatin. During this period, pre-transplant evaluation is proposed to begin if there is no progression and\u002For to assess inclusion on the transplant waiting list, depending on the estimated waiting time.\n\nA staging laparotomy\u002Flaparoscopy is recommended before including the patient in waiting list for transplant to confirm the abscence of extra-hepatic disease, especially peritoneal seeding and lymph nodes involvement.\n\nA score exception will be allowed to optimized the treatment received and to be transplanted during the first 6 months.\n\nLIVER TRANSPLANT AND FOLLOW-UP\n\nRegarding liver transplant technique, the hepatic artery should be avoided for arterial reconstruction using the splenic artery or an iliac conduit.\n\nNGS analyses in the explant specimen will be performed.\n\nThe patient will be monitored post-operatively at the clinical, biological, and morphological levels every 3 months during the first 2 years and every 6 months thereafter, in the context of standard clinical care, to detect any recurrence.","Those patients with unresectable malignant appearing hilar stricture and at least one of the following:\n\n* Malignant cytology or histology\n* CA 19.9\\>130U\u002FmL without cholangits or\u002Fand jaundice\n* Mass on cross-sectional imaging",[26],{"label":27,"type":11,"description":28,"interventionNames":29},"Study group","Patients with unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases",[30,31],"Drug: Neoadjuvant Chemo-radiotherapy","Procedure: Liver Transplantation",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"DRUG","Neoadjuvant Chemo-radiotherapy","Patients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg\u002Fm2 bid).Thereafter, gemcitabine iv (1000mg\u002Fm2) plus cisplatin iv (25mg\u002Fm2) will be administered the day 1 and 8 every 21 days until transplant.",[27],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"PROCEDURE","Liver Transplantation","If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.",[27],[44,48,51,54,57,60,63,66,69,72,75,78,81,84,88,90,93,95,98,101,104,107,110,113],{"name":45,"affiliation":46,"role":47},"Sonia Pascual-Bartolomé","HOSPITAL GENERAL UNIVERSITARIO, ALICANTE","STUDY_CHAIR",{"name":49,"affiliation":50,"role":47},"Carmelo Loinaz-Segurola","HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRID",{"name":52,"affiliation":53,"role":47},"José María Álamo-Martinez","HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA",{"name":55,"affiliation":56,"role":47},"José Luis Lucena de la Poza","Hospital Universitario Puerta de Hierro Majadahonda",{"name":58,"affiliation":59,"role":47},"Arturo Colon-Rodríguez","HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID",{"name":61,"affiliation":62,"role":47},"Diego López-Segarra","COMPLEJO HOSPITALARIO UNIVERSITARIO, BADAJOZ",{"name":64,"affiliation":65,"role":47},"Yilliam Fundora-Suárez","Hospital Clinic of Barcelona",{"name":67,"affiliation":68,"role":47},"Eva Montalvá-Orón","Hospital Universitario La Fe",{"name":70,"affiliation":71,"role":47},"Juan Andrés Echeverri-Cifuentes","HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA, SANTANDER",{"name":73,"affiliation":74,"role":47},"María Teresa Salcedo-Allende","HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA",{"name":76,"affiliation":77,"role":47},"José Antonio Gracia Solanas","HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA, ZARAGOZA",{"name":79,"affiliation":80,"role":47},"Adriá Rosat-Rodrigo","HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE LA CANDELARIA, TENERIFE",{"name":82,"affiliation":83,"role":47},"Victor Lopez-Lopez","Hospital Universitario Virgen de la Arrixaca",{"name":85,"affiliation":86,"role":87},"Laura Lladó-Garrida","HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA","STUDY_DIRECTOR",{"name":89,"affiliation":65,"role":87},"María Teresa Macarulla-Mercadé",{"name":91,"affiliation":92,"role":87},"Begoña Navalpotro-Yagüe","HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA",{"name":94,"affiliation":92,"role":47},"Jaume Capdevila",{"name":96,"affiliation":97,"role":47},"Julio Santoyo","HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA",{"name":99,"affiliation":100,"role":47},"Manuel Durán Martínez","HOSPITAL UNIVERSITARIO REINA SOFIA DE CÓRDOBA",{"name":102,"affiliation":103,"role":47},"Natalia Zambudio","Hospital Virgen de las Nieves (Granada)",{"name":105,"affiliation":106,"role":47},"Mikel Gastaka","Hospital Universitario de Cruces",{"name":108,"affiliation":109,"role":47},"Manuel Abradelo","Hospital Universitario de Toledo",{"name":111,"affiliation":112,"role":47},"Dora Gómez-Pasantes","Complejo Hospitalario Universitario, A Coruña",{"name":114,"affiliation":115,"role":47},"Carmen Bernardo","Hospital Universitario Central de Asturias",[117],{"name":118,"role":119,"phone":120,"phoneExt":11,"email":121},"CRISTINA DOPAZO, MD\u002FPhD","CONTACT","+34932746113","cristina.dopazo@vallhebron.cat",[123],{"facility":124,"status":125,"city":126,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"Department of HPB Surgery and Transplants, Hospital Vall d´Hebron","RECRUITING","Barcelona","08035","Spain","ES",{"type":131,"coordinates":132},"Point",[133,134],2.15899,41.38879,{"lat":134,"lon":133},[137],{"name":138,"role":119,"phone":139,"phoneExt":140,"email":121},"Cristina Dopazo, PhD\u002FMD","+34932746000","6113",{"type":142,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Cristina Dopazo Taboada","Consultant Surgeon","100391518",false,"NCT04378023","Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.","Inclusion Criteria:\n\n* Willing and able to provide written consent form\n* Age ≤ 70 years-old\n* ECOG 0 or 1\n* Unresectable hCCA ≤3cm in radial diameter\n\nExclusion Criteria:\n\n* Those patients who have received chemotherapy or radiotherapy previously out of protocol\n* Liver, extrahepatic or lymph node metastases\n* Previous intent of surgical resection or percutaneous biopsy\n* Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.\n* Infection no controlled","ALL","18 Years","70 Years",{"count":154,"type":155},34,"ESTIMATED","5 Years","OBSERVATIONAL","A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.\n\nThe primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.",[160],"Unresectable Cholangiocarcinoma","2026-05-21",{"date":163,"type":164},"2026-05-26","ACTUAL",{"date":166,"type":164},"2020-04-24",{"date":168,"type":155},"2027-06-01",{"name":5,"class":6},1]