[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563758":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":41,"responsibleParty":55,"collaborators":57,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":36,"enrollmentInfo":89,"targetDuration":36,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":43,"whyStopped":36,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanical dilator","EXPERIMENTAL","Dilation of the needle tract is initially performed with an ultra-tapered mechanical dilator (7Fr ES Dilator; Zeon Medical Co., Tokyo, Japan).",[13],"Procedure: endoscopic ultrasonography-guided biliary drainage",{"label":15,"type":16,"description":17,"interventionNames":18},"Electrocautery dilator","ACTIVE_COMPARATOR","Dilation of the needle tract is initially performed with a diathermic sheath (6Fr Cyst-Gastro set; Endoflex, Voerde, Germany).",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","endoscopic ultrasonography-guided biliary drainage","Skilled endosonographers performed EUS-BD with patients under conscious sedation by intravenous medication. All patients were given intravenous antibiotics prophylactically. A therapeutic curved linear array echoendoscope is positioned in the stomach with carbon dioxide insufflation. Standard 19G fine needles are used to puncture the dilated left intrahepatic bile duct or commo bile duct. Bile juice aspiration with 20ml syringe was performed to confirm intraductal puncture. After contrast medium injection, an insulated guidewire (0.025 inch VisiGlide2; Olympus Medical Systems, Tokyo, Japan) is advanced antegradely.\n\nDilation of the needle tract is initially performed with a diathermic sheath (6Fr Cyst-Gastro set; Endoflex, Voerde, Germany) or an ultra-tapered mechanical dilator (7Fr ES Dilator; Zeon Medical Co., Tokyo, Japan) according to randomization result. If needed, additional dilation can be attempted with dilating balloon. Finally, the dedicated plastic stent or partially cover",[15,9],[26],"EUS-BD",[28],{"name":29,"affiliation":5,"role":30},"Hsiu-Po Wang","STUDY_DIRECTOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Yu-Ting Kuo","CONTACT","+886972652398",null,"sfstruck@gmail.com",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":36},"Hung-Yao Lin","+886972654673",[42],{"facility":5,"status":43,"city":44,"state":36,"zip":36,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Taipei","Taiwan","TW",{"type":48,"coordinates":49},"Point",[50,51],121.52639,25.05306,{"lat":51,"lon":50},[54],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":56,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[58,60,62,64,66,68,70,73,75,77],{"name":59,"class":6},"National Taiwan University Hospital Hsin-Chu Branch",{"name":61,"class":6},"Taichung Veterans General Hospital",{"name":63,"class":6},"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",{"name":65,"class":6},"Far Eastern Memorial Hospital",{"name":67,"class":6},"China Medical University Hospital",{"name":69,"class":6},"Chung Shan Medical University",{"name":71,"class":72},"Taitung Mackay Memorial Hospital","UNKNOWN",{"name":74,"class":6},"National Cheng-Kung University Hospital",{"name":76,"class":6},"Chang Gung Memorial Hospital",{"name":78,"class":6},"Shin Kong Wu Ho-Su Memorial Hospital","100563758","safety-and-efficacy-of-mechanical-versus-electrocautery-dilator-for-eus-guided-biliary-drainage-med-bd-100563758",false,"NCT06620328","Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD)","Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial","MED-BD","Inclusion Criteria:\n\n* Failed ERCP\n* The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction\n* Contraindications for PTCD such as ascites and possibility of self-tube removal\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":90,"type":91},64,"ESTIMATED","INTERVENTIONAL",[94],"NA","The purpose of this study is to investigate the likelihood of post-dilation bleeding using mechanical or electrocautery dilation. We hypothesized that the risk of bleeding is lower in the mechanical group.",[97],"Biliary Obstruction",[99,100,9,15,101],"Endoscopic ultrasound","Biliary drainage","Interventional EUS","2026-01-11",{"date":104,"type":105},"2026-01-13","ACTUAL",{"date":107,"type":105},"2025-07-03",{"date":109,"type":91},"2026-12-31",{"name":5,"class":6},1]