Early shunt procedure tested in people with cirrhosis and fluid in the belly
Tests an early TIPS shunt against standard drug care in adults with cirrhosis and ascites.
Plain-language title generated from the registry record
Registry title: Early TIPS in Patients With Liver Cirrhosis and Ascites
Key facts
- Where
- Freiburg im Breisgau, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cirrhosis whose first complication is fluid in the belly (ascites). It compares an early shunt procedure (TIPS) with standard treatment.
- Age
- From 18 years up to under 80 years.
- Sex
- All sexes can join.
- Disease stage
- Liver cirrhosis with ascites as the first single complication: grade 2 ascites with MELD 15 or higher, or grade 3 ascites. INR 1.5 or lower.
- Earlier treatment
- Cannot have had a TIPS before or a liver transplant. Cannot have treatment-refractory or recurrent ascites.
Main reasons for not taking part
- Bilirubin above 3 mg/dl
- Significant heart disease (NYHA II or higher) or left ventricular ejection fraction 50% or lower
- Portal vein thrombosis, Budd-Chiari syndrome or spontaneous bacterial peritonitis
- Active cancer needing treatment, including liver cancer
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06576934, who can take part
Where in Germany
- University Medical Center FreiburgFreiburg im Breisgau, GermanyContact: Dominik Bettinger, Prof. Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital Freiburg
- Trial code
- NCT06576934
- Record updated
- 1 May 2026
- Original description
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.Read full original descriptionShow less
Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial
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.
By 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.
Inclusion: Patients eligible for inclusion in this trial must meet all of the following criteria:; Patients ≥ 18 years and < 80 years; Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features; Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites; INR ≤ 1.5; Ability to understand the nature of the trial and the trial related procedures and to comply with them.
Exclusion: Patients with concomitant variceal bleeding fulfilling the criteria for pre-emptive TIPS implantation (Child-Pugh class C < 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); Patient after liver transplantation; Prior TIPS implantation; Budd-Chiari syndrome; Portal vein thrombosis (PVT); Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease); Clinical significant cardiac disease (NYHA ≥II); Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves); Pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg); Hepatorenal syndrome type AKI (HRS-AKI); Acute on chronic liver failure; Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment; New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months; Untreated chronic hepatitis C virus (HCV) infection; Uncontrolled systemic infection (defined as an increase of > 20% if inflammatory parameters [C-reactive protein, procalcitonin, leukocytes] and/or sepsis as a reason for development of ascites; Reduced left ventricular ejection fraction ≤50%; Bilirubin > 3 mg/dl; Patients eligible for this trial must not meet any of the following criteria:; Treatment refractory or recurrent ascites at the time of study inclusion; Spontaneous bacterial peritonitis (SBP); Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE); Obstructive cholestasis; Benign liver tumor within the potential puncture tract; Ongoing and/or recurrent hepatic encephalopathy (grade >II); Life expectancy <1 year; Pregnant or breastfeeding women; Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study; Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed; Person who is in a relationship of dependence/employment with the sponsor or the investigator.