[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605889":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":24,"responsibleParty":41,"collaborators":24,"id":44,"slug":24,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":24,"enrollmentInfo":53,"targetDuration":24,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":24},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-selective beta blockers","ACTIVE_COMPARATOR","Non-selective beta blockers prescribed according to standard of care treatment guidelines. These may include propranolol, nadolol, and timolol.",[13],"Drug: Non-selective beta blockers",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrograde transvenous obliteration (RTO)","Pre-emptive treatment with retrograde transvenous obliteration",[18],"Procedure: Retrograde transvenous obliteration",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Non-selective beta blockers are used in patients who have not had a previous variceal bleed to prevent bleeding by reducing blood pressure in the liver. These drugs also work by blocking beta receptors that reduce cardiac output and by causing vessel constriction in the abdominal organs, which lowers blood flow to the liver and the existing varices.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Retrograde transvenous obliteration","Pre-emptive retrograde transvenous obliteration will be performed in patients randomized to this arm to evaluate the effectiveness in decreasing gastric variceal bleeding. Either CARTO or PARTO (coil or plug-assisted retrograde transvenous obliteration) will be performed using EMBOLIZATION COILS or VASCULAR PLUGS of different sizes based on the size of the shunt. Additionally, Gelfoam (collagen sponges) slurry will be injected into the shunt and varices to completely obliterate them.",[15],[31],"CARTO, PARTO, BRTO, RTO, RTOs",[33],{"name":34,"affiliation":5,"role":35},"Edward W. Lee, MD, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","310-267-8771","edwardlee@mednet.ucla.edu",{"type":35,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Edward Wolfgang Lee, MD","Principal Investigator","100605889",false,"NCT07168395","Pre-emptive RTO for An Early Detected Gastric Varices in CT\u002FMR Angiogram Trial","Pre-emptive RTO for An Early Detected Gastric Varices in CT\u002FMR Angiogram Trial (PRADA Trial)","PRADA","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Patients with compensated cirrhosis with a higher risk of decompensation based on AASLD 2023 Practice Guidance (Kaplan et al) - no ascites with endoscopic visualization of varices\n3. Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.\n4. No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy\n5. MELD \\\u003C 20\n6. First de novo RTO procedure\n7. Taking NSBB\n8. Patent internal jugular or right common femoral vein\n9. Willing to provide the hepatology service information for F\u002FU\n10. No known diagnosis of hypercoagulopathy\n11. Patent portal vein or portal vein cavernous transformation\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)\n3. Cardiac failure\n4. Active variceal bleeding\n5. History of gastroesophageal variceal bleeding\n6. Previous TIPS, BRTO, CARTO or PARTO procedure\n7. No right jugular or right common femoral venous access\n8. No portal vein flow\n9. Malignancy\n10. Life expectancy of less than 6 months","ALL","18 Years",{"count":54,"type":55},68,"ESTIMATED","INTERVENTIONAL",[58],"NA","A number of treatment modalities are currently in use for gastric variceal bleeding (GVB). Balloon-occluded, plug-assisted, and coil-assisted retrograde transvenous obliteration (RTO) procedures are described in the literature as treatments for GVB after a bleeding episode occurs. Preliminary data suggests that prophylactic treatment of gastric varices may improve patient outcomes compared to conservative management. This study aims to compare pre-emptive treatment of gastric varices with current recommended medical management in a randomized prospective study design. Eligible patients will be randomized to receive RTO or to continue conservative management. Patients will be followed for up to 2 years for comparison of clinical outcomes, including episodes of gastric variceal bleeding, overall survival and transplant-free survival, complications, and secondary interventions.",[61],"Gastric Varices",[63,64,65,66,67,68,69],"varices","stomach","gastric","hepatic encephalopathy","gastric variceal bleeding","bleeding","retrograde transvenous obliteration","NOT_YET_RECRUITING","2026-07-01",{"date":73,"type":74},"2026-07-02","ACTUAL",{"date":76,"type":55},"2026-10",{"date":78,"type":55},"2028-11",{"name":5,"class":6}]