[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624273":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gentamicin arm","EXPERIMENTAL","In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm).\n\nPatients will receive intraductal antibiotic Gentamicin 80mg(2ml) diluted in 20cc distilled water during ERCP.",[13],"Drug: Gentamicin - single dose",{"label":15,"type":16,"description":17,"interventionNames":18},"Distilled water arm","ACTIVE_COMPARATOR","In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm).\n\nPatients will receive intraductal distilled water 20cc during ERCP.",[19],"Drug: Distilled water",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gentamicin - single dose","Administration described in arm\u002Fgroup description",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Distilled water",[15],[31],{"name":32,"affiliation":33,"role":34},"Azlanudin Azman","Universiti Kebangsaan Malaysia Medical Centre","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Tiew Toot Chaw","CONTACT","+60176175253","warrentiew@gmail.com",{"name":32,"role":38,"phone":42,"phoneExt":26,"email":43},"+60192817878","drazlan@ppukm.ukm.my",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":26,"geoPoint":26,"contacts":53},"Hospital Canselor Tuanku Muhriz UKM","RECRUITING","Cheras","Kuala Lumpur","56000","Malaysia","MY",[54,55,56,57],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":32,"role":38,"phone":42,"phoneExt":26,"email":43},{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Ian Chik","SUB_INVESTIGATOR",{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof Madya Dr. Azlanudin Azman","Associate Professor","100624273","phase-2-comparative-efficacy-of-intraductal-antibiotic-during-ercp-in-acute-cholangitis-100624273",false,"NCT07407491","Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis","Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The patients diagnosed with mild and moderate acute cholangitis based on TG 18\n* Planned for ERCP within 48 hours\n* 18 years old and above\n\nExclusion Criteria:\n\n* Severe acute cholangitis\n* History of antibiotic hypersensitivity\n* Receiving cancer chemotherapy, steroids, or immunosuppressive agents\n* Concomitant infections\n* Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months\n* Known or suspected perforated tympanic membrane, myasthenia gravis","ALL","18 Years",{"count":73,"type":74},172,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?",[80,81,82,83,84],"Acute Cholangitis","Biliary Tract Infection","Biliary Obstruction","Choledocholithiasis","Malignant Biliary Stricture",[80,86,87,88,83],"ERCP","Intraductal antibiotics","Biliary tract infection","2026-02-05",{"date":91,"type":92},"2026-02-12","ACTUAL",{"date":94,"type":92},"2024-07-09",{"date":96,"type":74},"2026-07-08",{"name":5,"class":6},1]