[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560422":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":51,"collaborators":55,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University Hospital Freiburg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transjugular intrahepatic portosystemic shunt (TIPS)","EXPERIMENTAL","Patients will receive TIPS implantation if ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites occurs.",[13],"Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard medical treatment","NO_INTERVENTION","Patients in this group will receive standard medical treatment according to the current EASL guidelines (salt restriction, diuretic treatment, carvedilol, large-volume paracentesis if necessary, albumin substitution if more than 5 litre of ascites is removed)",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Dominik Bettinger, MD","CONTACT","+4976127036870","dominik.bettinger@uniklinik-freiburg.de",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Marco Janoschke, PhD","+4976127077831","marco.janoschke@uniklinik-freiburg.de",[35],{"facility":36,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Medical Center Freiburg","RECRUITING","Freiburg im Breisgau","79106","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],7.85222,47.9959,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":28,"phoneExt":18,"email":29},"Dominik Bettinger, Prof. Dr.",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Dominik Bettinger","Principal Investigator",[56,58,60,62,64,66,68,70,72,74],{"name":57,"class":6},"Jena University Hospital",{"name":59,"class":6},"Johannes Gutenberg University Mainz",{"name":61,"class":6},"University Hospital Muenster",{"name":63,"class":6},"University Hospital, Bonn",{"name":65,"class":6},"University Hospital Munich",{"name":67,"class":6},"Hannover Medical School",{"name":69,"class":6},"University of Leipzig",{"name":71,"class":6},"University Hospital, Aachen",{"name":73,"class":6},"University Hospital Lübeck",{"name":75,"class":6},"Heinrich-Heine University, Duesseldorf","100560422","early-tips-in-patients-with-liver-cirrhosis-and-ascites-100560422",false,"NCT06576934","Early TIPS in Patients With Liver Cirrhosis and Ascites","Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial","eTIPS","Inclusion Criteria:\n\nPatients eligible for inclusion in this trial must meet all of the following criteria:\n\n1. Patients ≥ 18 years and \\\u003C 80 years\n2. Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features\n3. Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites\n4. INR ≤ 1.5\n5. Ability to understand the nature of the trial and the trial related procedures and to comply with them\n\nExclusion Criteria:\n\nPatients eligible for this trial must not meet any of the following criteria:\n\n1. Treatment refractory or recurrent ascites at the time of study inclusion\n2. Patients with concomitant variceal bleeding fulfilling the criteria for pre-emptive TIPS implantation (Child-Pugh class C \\\u003C 14 points or Child-Pugh class B \\>7 with active bleeding at initial endoscopy or hepatic venous pressure gradient \\[HVPG\\] \\> 20 mmHg at the time of bleeding)\n3. Budd-Chiari syndrome\n4. Portal vein thrombosis (PVT)\n5. Spontaneous bacterial peritonitis (SBP)\n6. Uncontrolled systemic infection (defined as an increase of \\> 20% if inflammatory parameters \\[C-reactive protein, procalcitonin, leukocytes\\] and\u002For sepsis as a reason for development of ascites\n7. Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)\n8. Clinical significant cardiac disease (NYHA ≥II)\n9. Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)\n10. Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)\n11. Reduced left ventricular ejection fraction ≤50%\n12. Pulmonary hypertension (mean pulmonary arterial pressure \\> 45 mmHg)\n13. Bilirubin \\> 3 mg\u002Fdl\n14. Obstructive cholestasis\n15. Hepatorenal syndrome type AKI (HRS-AKI)\n16. Acute on chronic liver failure\n17. Benign liver tumor within the potential puncture tract\n18. Patient after liver transplantation\n19. Prior TIPS implantation\n20. Ongoing and\u002For recurrent hepatic encephalopathy (grade \\>II)\n21. Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment\n22. New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months\n23. Untreated chronic hepatitis C virus (HCV) infection\n24. Life expectancy \\\u003C1 year\n25. Pregnant or breastfeeding women\n26. Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study\n27. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n28. Person who is in a relationship of dependence\u002Femployment with the sponsor or the investigator","ALL","18 Years","80 Years",{"count":88,"type":89},134,"ESTIMATED","INTERVENTIONAL",[92],"NA","The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event.\n\nBy creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.",[95,96,97],"Liver Cirrhosis","Ascites Hepatic","Portal Hypertension",[99,100,101,102],"liver cirrhosis","Transjugular intrahepatic portosystemic shunt","ascites","MELD","2026-04-27",{"date":105,"type":106},"2026-05-01","ACTUAL",{"date":108,"type":106},"2025-04-01",{"date":110,"type":89},"2029-02-15",{"name":5,"class":6},1]