[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634169":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":58,"overallOfficials":68,"centralContacts":73,"locations":78,"responsibleParty":135,"collaborators":37,"id":138,"slug":37,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":37,"enrollmentInfo":147,"targetDuration":37,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":80,"whyStopped":37,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Aichi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Success Rate","Clinical success is defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Improvement includes resolution of fever, abdominal pain, and inflammatory findings such as leukocytosis. The primary analysis will be performed in the intention-to-treat population.","Within 14 days after the index gallbladder drainage procedure",[14,18,22,26,29,33],{"measure":15,"description":16,"timeFrame":17},"Technical Success Rate","Technical success is defined as successful completion of the assigned gallbladder drainage procedure with appropriate stent placement in the gallbladder.","At the index procedure",{"measure":19,"description":20,"timeFrame":21},"Adverse Event Rate","Adverse events related to the gallbladder drainage procedure will be recorded, including bile leak, bleeding, stent migration, stent occlusion, pancreatitis, cholangitis, liver abscess, gastrointestinal perforation, biliary peritonitis, and aspiration pneumonia.","Within 14 days after the index procedure, with additional follow-up assessed up to 3 year",{"measure":23,"description":24,"timeFrame":25},"Reintervention Rate","Reintervention is defined as any additional procedure required after the initial gallbladder drainage for recurrent cholecystitis, insufficient drainage, stent-related complications, or other biliary events including cholangitis or common bile duct stones.","Within 30 days after the index procedure, with additional follow-up assessed up to 3 year",{"measure":27,"description":28,"timeFrame":17},"Procedure Time","Procedure time is defined as the time in minutes from endoscope insertion to endoscope removal during the initial gallbladder drainage procedure.",{"measure":30,"description":31,"timeFrame":32},"Length of Hospital Stay","Length of hospital stay is defined as the number of days from the initial study intervention to hospital discharge.","From the index procedure to hospital discharge, up to 30 days",{"measure":34,"description":35,"timeFrame":36},"30-Day Mortality","All-cause mortality within 30 days after gallbladder drainage will be assessed. Cause of death, including whether it was related to cholecystitis or the procedure, will be recorded when available.","Within 30 days after the index procedure",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","Acute calculous cholecystitis is a common condition for which early laparoscopic cholecystectomy is the standard treatment. However, some patients are poor surgical candidates because of advanced age, severe comorbidities, poor performance status, or refusal of surgery. In such cases, gallbladder drainage is required.\n\nEndoscopic gallbladder drainage has become an alternative to percutaneous drainage because it avoids external drainage tubes and may improve patient comfort and quality of life. Endoscopic transpapillary gallbladder drainage (EGBS) is an established endoscopic approach, but it is technically challenging because selective cannulation of the cystic duct is often difficult. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) has recently emerged as a promising alternative with high technical and clinical success rates. However, prospective randomized evidence directly comparing EUS-GBD with EGBS is lacking.\n\nThis study is a multicenter, prospective, parallel-group, open-label randomized controlled trial designed to compare EUS-GBD and EGBS in poor surgical candidates with acute calculous cholecystitis. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to either the EUS-GBD group or the EGBS group using a web-based central registration system. In the EUS-GBD group, gallbladder drainage will be performed under endoscopic ultrasound guidance using a commercially available LAMS. In the EGBS group, gallbladder drainage will be performed by a transpapillary approach with placement of a plastic stent. Procedures will be performed as early as possible after enrollment, preferably within 24 hours.\n\nThe primary endpoint is clinical success, defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, procedure-related adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. Long-term follow-up data, including recurrent cholecystitis, late adverse events, reinterventions, and survival, will also be collected.\n\nThe study aims to establish high-level evidence regarding the optimal endoscopic gallbladder drainage strategy for poor surgical candidates with acute calculous cholecystitis.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD)","EXPERIMENTAL","Participants undergo endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a commercially available lumen-apposing metal stent (LAMS). The gallbladder is punctured from the duodenum or stomach under endoscopic ultrasound guidance, and the stent is deployed to create internal gallbladder drainage.",[51],"Procedure: Endoscopic Ultrasound-Guided Gallbladder Drainage",{"label":53,"type":54,"description":55,"interventionNames":56},"Endoscopic Transpapillary Gallbladder Drainage (EGBS)","ACTIVE_COMPARATOR","Participants undergo endoscopic transpapillary gallbladder drainage by ERCP-based cannulation of the bile duct and cystic duct, followed by placement of a plastic stent into the gallbladder.",[57],"Procedure: Endoscopic Transpapillary Gallbladder Drainage",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":37},"PROCEDURE","Endoscopic Ultrasound-Guided Gallbladder Drainage","Endoscopic ultrasound-guided gallbladder drainage performed using a commercially available lumen-apposing metal stent (AXIOS™, Boston Scientific). The procedure is performed under endoscopic ultrasound guidance through the stomach or duodenum to achieve internal gallbladder drainage.",[47],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":37},"Endoscopic Transpapillary Gallbladder Drainage","Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.",[53],[69],{"name":70,"affiliation":71,"role":72},"Tadahisa Inoue","Department of Gastroenterology, Aichi Medical University","STUDY_CHAIR",[74],{"name":70,"role":75,"phone":76,"phoneExt":37,"email":77},"CONTACT","+81561623311","tinoue-tag@umin.ac.jp",[79,92,105,115,125],{"facility":5,"status":80,"city":81,"state":37,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Aichi","Japan","JP",{"type":85,"coordinates":86},"Point",[87,88],130.62158,32.51879,{"lat":88,"lon":87},[91],{"name":70,"role":75,"phone":76,"phoneExt":37,"email":77},{"facility":93,"status":80,"city":94,"state":37,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Gifu Municipal Hospital","Gifu",{"type":85,"coordinates":96},[97,98],136.76039,35.42291,{"lat":98,"lon":97},[101],{"name":102,"role":75,"phone":103,"phoneExt":37,"email":104},"Keisuke Iwata","+81582511101","keisukeiwata827@gmail.com",{"facility":106,"status":80,"city":94,"state":37,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Gifu Prefectural General Medical Center",{"type":85,"coordinates":108},[97,98],{"lat":98,"lon":97},[111],{"name":112,"role":75,"phone":113,"phoneExt":37,"email":114},"Naoki Mita","+81582461111","mitanao8@yahoo.co.jp",{"facility":116,"status":80,"city":94,"state":37,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":117,"geoPoint":119,"contacts":120},"Gifu University Hospital",{"type":85,"coordinates":118},[97,98],{"lat":98,"lon":97},[121],{"name":122,"role":75,"phone":123,"phoneExt":37,"email":124},"Shinya Uemura","+81582306000","ueshin550621@gmail.com",{"facility":126,"status":80,"city":94,"state":37,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Matsunami General Hospital",{"type":85,"coordinates":128},[97,98],{"lat":98,"lon":97},[131],{"name":132,"role":75,"phone":133,"phoneExt":37,"email":134},"Mitsuru Okuno","+81583880111","mkobdkl@yahoo.co.jp",{"type":136,"investigatorFullName":70,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Associate Professor","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":148,"type":149},90,"ESTIMATED","INTERVENTIONAL",[152],"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.",[155],"Acute Calculous Cholecystitis",[155,61,157,158],"Endoscopic Gallbladder Stenting","Poor Surgical Candidates","2026-04-11",{"date":161,"type":162},"2026-04-17","ACTUAL",{"date":164,"type":149},"2026-04-15",{"date":166,"type":149},"2030-12-31",{"name":5,"class":6},5]