[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656764":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":16,"studyPopulation":16,"armGroups":48,"interventions":61,"overallOfficials":16,"centralContacts":16,"locations":69,"responsibleParty":91,"collaborators":93,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":16,"enrollmentInfo":124,"targetDuration":16,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":71,"whyStopped":16,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrent biliary obstruction (RBO) rate","the proportion of participants experiencing RBO, defined by cholangitis, jaundice or findings of images, from index day of EUS-BD to the date of last follow-up","From enrollment to the end of follow-up up to 12 months",[14,18,22,26,29,32,36,39],{"measure":15,"description":16,"timeFrame":17},"Time to Recurrent Biliary Obstruction",null,"From date of enrollment until the date of first documented recurrent biliary obstruction, date of death from any cause or date of last follow-up, whichever came first, assessed up to 12 months",{"measure":19,"description":20,"timeFrame":21},"Tract dilation success","tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct","From the start of the EUS-BD to completion or failure of dilation, assessed on the day of the drainage procedure",{"measure":23,"description":24,"timeFrame":25},"Final procedure success","a successful deployment of a stent in the intended location","From the start of the EUS-BD to completion or failure of stent deployment, assessed on the day of the drainage procedure",{"measure":27,"description":16,"timeFrame":28},"Procedural duration","The time elapsed between puncture of the intrahepatic duct and completion of deployment of stent, assessed on the day of the drainage procedure.",{"measure":30,"description":16,"timeFrame":31},"Clinical success","a decrease in bilirubin within 14 days to \u003C 50 % of levels before EUS-BD",{"measure":33,"description":34,"timeFrame":35},"Adverse events","bleeding (hematemesis and\u002For melena or hemoglobin drop over 2g\u002FdL, needed blood transfusion, endoscopic hemostasis, radiological intervention or surgery), pancreatitis, cholangitis, peritonitis, and perforation, in accordance with the American Society for GI Endoscopy lexicon","From the day of procedure to the completion of follow-up up to 12 months",{"measure":37,"description":16,"timeFrame":38},"Length of hospital stay after procedure","From the day of procedure to discharge, assessed up to 12 months",{"measure":40,"description":16,"timeFrame":41},"Overall survival","Survival rate at the end of the follow-up period, assessed up to 12 months",{"allocation":43,"interventionModel":44,"interventionModelDescription":16,"primaryPurpose":45,"observationalModel":16,"timePerspective":16,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":16,"whoMasked":16},"NONE",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"HGS","ACTIVE_COMPARATOR","Endoscopic ultrasound guided hepaticogastrostomy",[54],"Device: HGS",{"label":56,"type":57,"description":58,"interventionNames":59},"HGAS","EXPERIMENTAL","Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla",[60],"Device: HGAS",[62,66],{"type":63,"name":56,"description":64,"armGroupLabels":65,"otherNames":16},"DEVICE","Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting",[56],{"type":63,"name":50,"description":67,"armGroupLabels":68,"otherNames":16},"Endoscopic ultrasound guided hepaticogastromy",[50],[70],{"facility":5,"status":71,"city":72,"state":16,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Taipei","100","Taiwan","TW",{"type":77,"coordinates":78},"Point",[79,80],121.52639,25.05306,{"lat":80,"lon":79},[83,88],{"name":84,"role":85,"phone":86,"phoneExt":16,"email":87},"Yu-Ting Kuo","CONTACT","886972652398","sfstruck@gmail.com",{"name":89,"role":85,"phone":90,"phoneExt":16,"email":16},"Hung-Yao Lin","886972653140",{"type":92,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[94,96,98,100,102,104,106,108,110,113],{"name":95,"class":6},"National Taiwan University Hospital Hsin-Chu Branch",{"name":97,"class":6},"Chang Gung Memorial Hospital",{"name":99,"class":6},"Taichung Veterans General Hospital",{"name":101,"class":6},"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",{"name":103,"class":6},"Shin Kong Wu Ho-Su Memorial Hospital",{"name":105,"class":6},"Far Eastern Memorial Hospital",{"name":107,"class":6},"China Medical University Hospital",{"name":109,"class":6},"Chung Shan Medical University",{"name":111,"class":112},"Taitung Mackay Memorial Hospital","UNKNOWN",{"name":114,"class":6},"National Cheng-Kung University Hospital","100656764","endoscopic-ultrasound-guided-hepaticogastrostomy-with-or-without-antegrade-stenting-for-palliation-of-malignant-distal-biliary-obstruction-randomized-controlled-trial-100656764",false,"NCT07832045","Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial","EASE-MBO","Inclusion Criteria:\n\n* Patients aged 18 years or older with malignant distal biliary obstruction\n* Failed ERCP\n* The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction\n\nExclusion Criteria:\n\n* Patients younger than 18 years old\n* Cancer infiltration of the gastric\u002Fduodenal wall within the planned puncture route\n* Patients with uncorrectable coagulopathy\n* Patients with unmanageable ascites\n* Patients with serious comorbidities that prohibited endoscopic management\n* Patients with pregnancy\n* Patients who cannot or refuse to provide informed consent","ALL","18 Years",{"count":125,"type":126},88,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.",[132,133],"Malignant Biliary Obstruction","Malignant Biliary Stricture",[135,136,137,138],"malignant biliary obstruction","EUS-guided hepaticogastrostomy","EUS-guided antegrade stenting","Biliary obstruction","2026-09-16",{"date":141,"type":142},"2026-09-21","ACTUAL",{"date":144,"type":142},"2026-04-01",{"date":146,"type":126},"2028-07",{"name":5,"class":6},1]