[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aichi Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100634169","gallvia-trial-eus-guided-vs-transpapillary-gallbladder-drainage-for-acute-calculous-cholecystitis-100634169",false,"NCT07536191","GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis","Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Endoscopic Transpapillary Gallbladder Drainage in Poor Surgical Candidates With Acute Calculous Cholecystitis: A Multicenter Randomized Controlled Trial (GALLVIA Trial)","GALLVIA","Inclusion Criteria:\n\n* Diagnosed with acute calculous cholecystitis according to the Tokyo Guidelines 2018 diagnostic criteria.\n* Poor surgical candidate for cholecystectomy, determined comprehensively based on clinical condition, including advanced age, comorbidities, performance status, anesthetic risk, or patient refusal of surgery.\n* Requires gallbladder drainage for treatment of acute cholecystitis.\n* Age 18 years or older at the time of consent.\n* Provides written informed consent before study enrollment.\n\nExclusion Criteria:\n\n* No gallstones identified.\n* Suspected gallbladder carcinoma.\n* Gallbladder perforation.\n* No gallbladder distension.\n* Surgically altered anatomy.\n* Concomitant common bile duct stones.\n* Bile duct stricture.\n* Massive ascites.\n* Gastric or duodenal stenosis.\n* Considered unsafe for endoscopic intervention.\n* Pregnant or possibly pregnant.\n* Judged unsuitable for the study by the investigator.","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, prospective, open-label, randomized controlled trial compares endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with endoscopic transpapillary gallbladder drainage (EGBS) in poor surgical candidates with acute calculous cholecystitis. Eligible patients will be randomized in a 1:1 ratio to undergo either EUS-GBD using a lumen-apposing metal stent or EGBS using a transpapillary plastic stent. The primary endpoint is clinical success, defined as successful gallbladder drainage with subsequent improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. The trial aims to determine whether EUS-GBD provides superior clinical outcomes compared with EGBS in this high-risk population.",[27],"Acute Calculous Cholecystitis",[27,29,30,31],"Endoscopic Ultrasound-Guided Gallbladder Drainage","Endoscopic Gallbladder Stenting","Poor Surgical Candidates","RECRUITING","2026-04-11",{"date":35,"type":36},"2026-04-17","ACTUAL",{"date":38,"type":21},"2026-04-15",{"date":40,"type":21},"2030-12-31",{"name":42,"class":43},"Aichi Medical University","OTHER",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":77},"100611009","repeated-endobiliary-radiofrequency-ablation-plus-durvalumab-gemcitabine-and-cisplatin-for-unresectable-extrahepatic-cholangiocarcinoma-100611009","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.",{"count":54,"type":21},120,[24],"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.",[58],"Extrahepatic Cholangiocarcinoma",[58,60,61,62,63,64,65,66,67,68,69],"Cholangiocarcinoma","Biliary Tract Cancer","Bile Duct Stricture","Endobiliary Radiofrequency Ablation (EB-RFA)","Radiofrequency Ablation","Endoscopic Retrograde Cholangiopancreatography (ERCP)","Gemcitabine","Cisplatin","Durvalumab","Recurrent Biliary Obstruction (RBO)","2026-01-11",{"date":72,"type":36},"2026-01-13",{"date":74,"type":36},"2025-11-20",{"date":40,"type":21},{"name":42,"class":43},8,""]