[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525516":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":59,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":43,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":43,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":43,"overallStatus":93,"whyStopped":43,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy","ACTIVE_COMPARATOR","Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol.\n\nStandard combined endoscopic and pharmacological therapy as secondary prophylaxis (carvedilol + repeated endoscopic variceal ligation until the eradication of the esophageal varices).",[13],"Procedure: standard second prophylaxis",{"label":15,"type":16,"description":17,"interventionNames":18},"Preemptive TIPS","EXPERIMENTAL","Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol.\n\nPerformance of TIPS in the first 72 hours following initial endoscopic hemostasis.",[19],"Procedure: preemptive TIPS",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","preemptive TIPS","The TIPS procedure should be performed within 72 hours after the initial endoscopic examination or treatment. An 8 mm Viatorr stent will be used for TIPS establishment. The aim will be to reduce the portal pressure gradient below 12 mm Hg. Embolization, either with coils or glue, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule but is allowed if the attending physician thinks that it is warranted.",[15],[27],"early TIPS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"standard second prophylaxis","Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (carvedilol) will be started with an initial dose of 6.25 mg, the dose of propranolol will be increased to 12.5 mg.\n\nThe second elective session of endoscopic band ligation will be performed within the first 28 days after the initial endoscopic treatment. The following sessions will be performed at 28 +\u002F- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.",[9],[33],"endoscopy plus drug treatment",[35],{"name":36,"affiliation":5,"role":37},"Xuefeng Luo, Ph.D.","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Xiazoe Wang, M.D.","CONTACT","+8615208207573",null,"wang_xiaoze@wchscu.cn",[46],{"facility":47,"status":43,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":43},"West China Hospital of Sichuan University","Chengdu","Sichuan","610000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],104.06667,30.66667,{"lat":57,"lon":56},{"type":37,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"luo xuefeng","Professor",[63,65,67,69],{"name":64,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":66,"class":6},"Beijing YouAn Hospital",{"name":68,"class":6},"Beijing Friendship Hospital",{"name":70,"class":6},"Beijing 302 Hospital","100525516","preemptive-tips-for-variceal-bleeding-in-cirrhotic-patients-with-occlusive-portal-vein-thrombosis-100525516",false,"NCT06122753","Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis","Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT): A Multicenter Randomized Trial","Inclusion Criteria:\n\n* Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);\n* Admission due to acute bleeding from esophagogastric varices;\n* Thrombus in the main trunk of the portal vein occupying ≥50% of the lumen.\n\nExclusion Criteria:\n\n* Prior treatment with TIPS or surgical shunt;\n* Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;\n* Presence of hepatocellular carcinoma exceeding Milan criteria;\n* Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;\n* Presence of uncontrollable infection or sepsis;\n* Presence of cardiac, pulmonary, or renal failure;\n* Pregnant or lactating women;\n* Refusal to sign the informed consent form.","ALL","18 Years","75 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"NA","Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.",[89,90,91,92],"Portal Hypertension","Portal Vein Thrombosis","Esophageal Varix Bleeding","Portosystemic Shunt","NOT_YET_RECRUITING","2023-11-03",{"date":96,"type":97},"2023-11-08","ACTUAL",{"date":99,"type":83},"2024-01",{"date":101,"type":83},"2026-12",{"name":5,"class":6},1]