[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646080":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":60,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":24,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Orlando Health, Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Percutaneous cholecystostomy","ACTIVE_COMPARATOR","Patients with acute calculous cholecystitis who are never-surgery candidates undergoing percutaneous cholecystostomy tube placement",[13],"Procedure: Percutaneous cholecystostomy",{"label":15,"type":10,"description":16,"interventionNames":17},"EUS-guided gallbladder drainage","Patients with acute calculous cholecystitis who are never-surgery candidates, undergoing EUS-guided gallbladder drainage",[18],"Procedure: EUS-guided gallbladder drainage",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Percutaneous cholecystostomy tube placement by interventional radiology",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"EUS-guided gallbladder drainage using metal stent",[15],[29],{"name":30,"affiliation":31,"role":32},"Ji Young Bang, MD MPH","Orlando Health, Digestive Health Institute","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","321-842-2273","jiyoung.bang@orlandohealth.com",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Barbara J Broome","321-841-4356","barbara.broome@orlandohealth.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Orlando Health Digestive Health Institute","RECRUITING","Orlando","Florida","32806","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.37924,28.53834,{"lat":55,"lon":54},[58,59],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100646080","randomized-trial-of-percutaneous-vs-endoscopic-gallbladder-drainage-100646080",false,"NCT07696546","Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage","Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial","PEG","Inclusion Criteria:\n\n* Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines\n* Age ≥ 18 years\n* Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery.\n* Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement.\n* Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study.\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients who are potential candidates for future cholecystectomy.\n* Patients unwilling to undergo follow-up assessments.\n* Patients with suspected gangrene or perforation of the gallbladder\n* Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis.\n* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.\n* Indwelling percutaneous cholecystostomy tube.\n* Refractory\u002Fpersistently significant ascites despite paracentesis.\n* Distance between the gallbladder and gastric\u002Fduodenal wall that cannot be bridged by the metal stent.\n* Abnormal coagulation parameters that cannot be correct: INR \\> 1.7 and\u002For platelets \\\u003C 50.000\u002Fmm3","ALL","18 Years",{"count":73,"type":74},110,"ESTIMATED","INTERVENTIONAL",[77],"NA","This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.",[80],"Acute Cholecystitis",[15,82,83,84,85],"percutaneous cholecystostomy","Acute calculous cholecystitis","Endoscopic ultrasound","Interventional radiology","2026-07-06",{"date":88,"type":89},"2026-07-10","ACTUAL",{"date":91,"type":74},"2026-07",{"date":93,"type":74},"2032-12",{"name":5,"class":6},1]