[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611009":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":102,"collaborators":26,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":26,"enrollmentInfo":114,"targetDuration":26,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Aichi Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Endobiliary Radiofrequency Ablation + Plastic Stent + Durvalumab\u002FGemcitabine\u002FCisplatin","EXPERIMENTAL","Participants undergo endobiliary radiofrequency ablation (EB-RFA) followed by placement of a plastic biliary stent during the index endoscopy. A scheduled second endoscopy at Month 3 (window 2-4 months) includes repeat EB-RFA and stent exchange. Additional EB-RFA sessions (≥2-month intervals) may be performed if imaging suggests a potentially ablatable residual biliary lesion. All participants receive systemic therapy with durvalumab, gemcitabine, and cisplatin according to institutional standards.",[13,14],"Device: Endobiliary Radiofrequency Ablation (EB-RFA)","Device: Plastic Biliary Stent",{"label":16,"type":17,"description":18,"interventionNames":19},"Plastic Stenting + Durvalumab\u002FGemcitabine\u002FCisplatin","ACTIVE_COMPARATOR","Participants receive standard endoscopic placement of a plastic biliary stent during the index endoscopy without EB-RFA. A scheduled elective stent exchange is performed at Month 3 (window 2-4 months). Additional elective stent exchanges every ≥2 months may be performed at the investigator's discretion. All participants receive systemic therapy with durvalumab, gemcitabine, and cisplatin according to institutional standards.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Endobiliary Radiofrequency Ablation (EB-RFA)","Endobiliary RFA performed using the ELRA® catheter (STARmed) with VIVA combo® generator.\n\nRecommended settings: 7-10 W, temperature control 80 °C, 120 seconds per application.\n\nApplied along the full stricture length. Repeat procedure at Month 3 (window 2-4 months).\n\nAdditional sessions every ≥2 months permitted if imaging suggests ablatable residual lesion.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Plastic Biliary Stent","Placement of 7Fr or 8.5Fr plastic biliary stent from hepatic side of the stenosis to the duodenum.\n\nBilateral preferred for hilar strictures; unilateral acceptable based on drainage.",[9,16],[32,36],{"name":33,"affiliation":34,"role":35},"Tadahisa Inoue, Associate Professor","Department of Gastroenterology, Aichi Medical University","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Jae Hee Cho, Professor","Department of Internal Medicine, Institute of Gastroenterology, Gangnam Severance Hospital, Yonsei University College of Medicine",[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Tadahisa Inoue","CONTACT","+81561623311","tinoue-tag@umin.ac.jp",[46,57,62,67,75,84,92,97],{"facility":5,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"RECRUITING","Aichi","Japan","JP",{"type":52,"coordinates":53},"Point",[54,55],130.62158,32.51879,{"lat":55,"lon":54},{"facility":58,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":59,"geoPoint":61,"contacts":26},"Nagoya City University Hospital",{"type":52,"coordinates":60},[54,55],{"lat":55,"lon":54},{"facility":63,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":66,"contacts":26},"Nagoya City University Midori Municipal Hospital",{"type":52,"coordinates":65},[54,55],{"lat":55,"lon":54},{"facility":68,"status":47,"city":69,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":26},"Gifu University Hospital","Gifu",{"type":52,"coordinates":71},[72,73],136.76039,35.42291,{"lat":73,"lon":72},{"facility":76,"status":47,"city":77,"state":26,"zip":26,"country":78,"countryCode":26,"cosmosGeoPoint":79,"geoPoint":83,"contacts":26},"Pusan National University Hospital","Busan","South Korea",{"type":52,"coordinates":80},[81,82],129.03004,35.10168,{"lat":82,"lon":81},{"facility":85,"status":47,"city":86,"state":26,"zip":26,"country":78,"countryCode":26,"cosmosGeoPoint":87,"geoPoint":91,"contacts":26},"Gangnam Severance Hospital, Yonsei University College of Medicine","Seoul",{"type":52,"coordinates":88},[89,90],126.9784,37.566,{"lat":90,"lon":89},{"facility":93,"status":47,"city":86,"state":26,"zip":26,"country":78,"countryCode":26,"cosmosGeoPoint":94,"geoPoint":96,"contacts":26},"Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine",{"type":52,"coordinates":95},[89,90],{"lat":90,"lon":89},{"facility":98,"status":47,"city":86,"state":26,"zip":26,"country":78,"countryCode":26,"cosmosGeoPoint":99,"geoPoint":101,"contacts":26},"Severance Hospital, Yonsei University College of Medicine",{"type":52,"coordinates":100},[89,90],{"lat":90,"lon":89},{"type":35,"investigatorFullName":41,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor","100611009","repeated-endobiliary-radiofrequency-ablation-plus-durvalumab-gemcitabine-and-cisplatin-for-unresectable-extrahepatic-cholangiocarcinoma-100611009",false,"NCT07235007","Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma","Survival Impact of Repeated Endobiliary Radiofrequency Ablation in Patients Undergoing Durvalumab Plus Gemcitabine and Cisplatin for Extrahepatic Cholangiocarcinoma: An International Multicenter Randomized Controlled Trial (BRAVE Trial)","BRAVE","Inclusion Criteria:\n\nHistologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA).\n\nUnresectable disease (unresectable due to tumor\u002Fpatient factors, or patient refusal of surgery).\n\nBiliary obstruction requiring drainage, demonstrated by abnormal cholestatic liver tests, elevated bilirubin, radiologic evidence, or existing biliary drainage.\n\nPlanned initiation of first-line systemic therapy with durvalumab + gemcitabine + cisplatin (GCD).\n\nAge ≥18 years.\n\nAble to provide written informed consent.\n\nExclusion Criteria:\n\nPrior radiotherapy or systemic therapy for the current eCCA.\n\nPresence of a self-expanding metal stent that cannot be endoscopically removed.\n\nSurgically altered anatomy except for Billroth-I; prior biliary reconstruction.\n\nHistory of chronic cholangitis (e.g., primary sclerosing cholangitis, IgG4-related cholangitis).\n\nExpected survival \\\u003C3 months.\n\nInability to insert an oral endoscope or reach the papilla.\n\nContraindication to endobiliary RFA.\n\nPregnancy or possible pregnancy.\n\nAny condition judged unsuitable by the investigator.","ALL","18 Years",{"count":115,"type":116},120,"ESTIMATED","INTERVENTIONAL",[119],"NA","This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic cholangiocarcinoma undergoing first-line systemic therapy with durvalumab plus gemcitabine and cisplatin (GCD). Eligible patients will be randomized 1:1 to EB-RFA with plastic stent placement or standard plastic stenting alone. A scheduled second endoscopic session will be performed at 3 months in both groups (repeat EB-RFA only in the EB-RFA arm). The primary endpoint is overall survival. Secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical\u002Fclinical success.",[122],"Extrahepatic Cholangiocarcinoma",[122,124,125,126,23,127,128,129,130,131,132],"Cholangiocarcinoma","Biliary Tract Cancer","Bile Duct Stricture","Radiofrequency Ablation","Endoscopic Retrograde Cholangiopancreatography (ERCP)","Gemcitabine","Cisplatin","Durvalumab","Recurrent Biliary Obstruction (RBO)","2026-01-11",{"date":135,"type":136},"2026-01-13","ACTUAL",{"date":138,"type":136},"2025-11-20",{"date":140,"type":116},"2030-12-31",{"name":5,"class":6},8]