[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613987":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":54,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"UDCA + Lactulose","EXPERIMENTAL","Ursodeoxycholic acid (UDCA) 13-15 mg\u002Fkg\u002Fday orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months. Lactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with stepwise dose reduction if diarrhea occurs.",[13,14],"Drug: Ursodeoxycholic Acid (UDCA)","Drug: Lactulose",{"label":16,"type":17,"description":18,"interventionNames":19},"Lactulose Alone","ACTIVE_COMPARATOR","Lactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with dose reduction as needed if diarrhea develops.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ursodeoxycholic Acid (UDCA)","13-15 mg\u002Fkg\u002Fday orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Lactulose","Syrup 25 mL BID, initiated after TIPS procedure, titrated to 1-2 soft stools\u002Fday, with dose reduction if diarrhea occurs.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaoze Wang, MD","CONTACT","(+86)15208207573","wang_xiaoze@wchscu.cn",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"West China Hospital, Sichuan University","Chengdu","China","CN",{"type":44,"coordinates":45},"Point",[46,47],104.06667,30.66667,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":53,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xiaoze Wang",[55,57,59,62],{"name":56,"class":6},"The Second Affiliated Hospital of Chongqing Medical University",{"name":58,"class":6},"First Affiliated Hospital of Kunming Medical University",{"name":60,"class":61},"Qianjiang Central Hospital of Chongqing","UNKNOWN",{"name":63,"class":61},"The Third People's Hospital of Kunming City","100613987","udca-to-prevent-post-tips-hepatic-encephalopathy-100613987",false,"NCT07273734","UDCA to Prevent Post-TIPS Hepatic Encephalopathy","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ursodeoxycholic Acid Plus Lactulose vs Lactulose Alone for the Prevention of Overt Hepatic Encephalopathy After TIPS Placement","THEUDCA","Inclusion Criteria:\n\n* Age 18-80 years.\n* Confirmed cirrhosis (biopsy, elastography, or standard radiologic\u002Fbiochemical criteria).\n* Elective TIPS for (a) refractory\u002Frecurrent ascites and\u002For (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers.\n* Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg.\n* Ability to start study drug within 72 hours before TIPS.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score \\>13, main-trunk PVT if not recanalizable, technical infeasibility).\n* Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's).\n* Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months.\n* Current\u002Frecent rifaximin use (\\\u003C3 months) or strong UDCA contraindication\u002Fhypersensitivity.\n* Salvage TIPS.\n* Non-cirrhotic portal hypertension.\n* Pregnancy\u002Flactation.\n* Any condition that, in investigators' judgment, precludes safe participation.","ALL","18 Years","80 Years",{"count":76,"type":77},270,"ESTIMATED","INTERVENTIONAL",[80],"NA","Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. This open-label multicenter randomized controlled trial tests whether adding UDCA (13-15 mg\u002Fkg\u002Fday) to standard lactulose prophylaxis reduces the incidence of overt HE (OHE; West Haven grade II-IV) after TIPS, compared with lactulose alone. The regimen starts within 72 hours before TIPS and continues for 3 months. The trial aims to evaluate the effect of UDCA in reducing the incidence of post-TIPS OHE.",[83,84],"Hepatic Encephalopathy (HE)","TIPS",[84,86,83,87],"UDCA","Ursodeoxycholic acid","NOT_YET_RECRUITING","2025-11-26",{"date":91,"type":92},"2025-12-09","ACTUAL",{"date":94,"type":77},"2026-01-01",{"date":96,"type":77},"2027-12-31",{"name":5,"class":6},1]