[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612423":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":59,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Air Force Military Medical University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard TIPS","ACTIVE_COMPARATOR","Standard TIPS Group: In the standard group, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg.",[13],"Procedure: Standard TIPS",{"label":15,"type":16,"description":17,"interventionNames":18},"Underdilated TIPS","EXPERIMENTAL","Underdilated TIPS Group:In this group, the TIPS stent was underdilated using a 6-mm balloon, and the immediate post-procedure portal pressure gradient (PPG) was measured.",[19],"Procedure: Underdilated TIPS",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The procedure will be performed via a transjugular approach, involving puncture from the hepatic vein or inferior vena cava into the portal venous system. Upon successful cannulation, direct portography will be performed to visualize varices and determine the optimal shunt tract, followed by targeted variceal embolization. A Novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \\& Associates, Arizona, USA) will then be deployed intrahepatically to establish the shunt. Subsequently, a 6-mm balloon will be used for suboptimal expansion of the TIPS stent, and the immediate portosystemic pressure gradient (PPG) will be measured.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"The procedure will be performed via a transjugular approach, with puncture conducted from the hepatic vein or inferior vena cava into the portal venous system. After successful cannulation, direct portography will be performed to visualize gastroesophageal varices and identify the optimal shunt tract, followed by targeted variceal embolization. A novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \\& Associates, Arizona, USA) will then be deployed intrahepatically to establish the transjugular intrahepatic portosystemic shunt (TIPS). Subsequently, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg.",[9],[30],{"name":31,"affiliation":5,"role":32},"Jun Tie","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Jun Tie, M.D.,Ph.D.","CONTACT","+862984771537","tiejun7776@163.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fourth Military Medical University","RECRUITING","Xi'an","Shaanxi","710032","China","CN",{"type":49,"coordinates":50},"Point",[51,52],108.92861,34.25833,{"lat":52,"lon":51},[55],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":32,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Tie Jun","Director of clinical research",[60,62,64,66],{"name":61,"class":6},"West China Hospital",{"name":63,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":65,"class":6},"Daping Hospital of Army Medical University",{"name":67,"class":6},"General Hospital of Ningxia Medical University","100612423","comparison-of-underdilated-versus-standard-tips-in-preventing-variceal-rebleeding-in-patients-with-cirrhosis-100612423",false,"NCT07253389","Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis","Comparison of Underdilated Versus Standard Transjugular Intrahepatic Portosystemic Shunt in Preventing Rebleeding From Esophagogastric Varices in Patients With Cirrhosis in Chinese Tertiary Hospitals: Protocol for a Multicenter Randomized Controlled Trial","UVR-TIPS","Inclusion Criteria:\n\n1\\. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive.\n\n3\\. High-risk acute variceal bleeding, defined as any of the following:\n\n1. High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score \\> 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score \\\u003C 14.\n2. Hepatic venous pressure gradient (HVPG) \\> 20 mmHg during bleeding.\n3. Early rebleeding within 5 days.\n4. Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment \\[endoscopy combined with non-selective beta-blockers (NSBB)\\]; or first hemorrhage accompanied by grade 2 ascites and\u002For portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy.\n\n5\\. Planned TIPS procedure. 6. Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension.\n2. Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs.\n3. Complete thrombosis of the main portal vein.\n4. Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia).\n5. Prior liver resection or liver transplantation.\n6. Prior TIPS or surgical portosystemic shunt.\n7. Pregnancy or lactation.\n8. Any contraindication to TIPS, including:\n\n(1) Congestive heart failure (New York Heart Association class C or D, or left ventricular ejection fraction \\\u003C 50%).\n\n(2) Severe pulmonary hypertension (mean pulmonary artery pressure \\> 45 mmHg as measured invasively).\n\n(3) Uncontrolled systemic infection. (4) Severe overt hepatic encephalopathy (OHE) with unmodifiable spontaneous portosystemic shunt.\n\n9.Acute hemorrhage with a MELD score ≥ 30 and\u002For arterial lactate \\> 12 mmol\u002FL, or presence of acute-on-chronic liver failure (ACLF).\n\n10\\. Systemic conditions requiring ongoing glucocorticoid or nonsteroidal anti-inflammatory drug (NSAID) therapy.","ALL","18 Years","75 Years",{"count":80,"type":81},648,"ESTIMATED","INTERVENTIONAL",[84],"NA","Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. In the management of gastroesophageal variceal bleeding, the primary goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O), which defines the standard TIPS procedure. The investigators hypothesize that, in patients undergoing TIPS for the prevention of variceal rebleeding, stent underdilation using a 6-mm balloon (underdilated TIPS) will not increase the risk of rebleeding but may reduce the incidence of overt HE and attenuate liver injury. To test this hypothesis, the investigators have designed a prospective, multicenter, randomized controlled trial.",[87,88],"Liver Cirrhosis","Gastroesophageal Varices Bleeding",[87,90,91,92],"Esophageal and gastric variceal bleeding","Transjugular intrahepatic portosystemic shunt","Hepatic encephalopathy","2026-06-06",{"date":95,"type":96},"2026-06-09","ACTUAL",{"date":98,"type":96},"2025-10-20",{"date":100,"type":81},"2029-09-30",{"name":5,"class":6},1]