Actively Recruiting
Early TIPS in Patients With Liver Cirrhosis and Ascites
Led by University Hospital Freiburg · Updated on 2026-05-01
134
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
University Hospital Freiburg
Lead Sponsor
J
Jena University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early TIPS in Patients With Liver Cirrhosis and Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 80 years
- Liver cirrhosis confirmed by biopsy or typical clinical, biochemical, and sonographic features
- Ascites as the first single decompensating event with grade 2 ascites and MELD score 15 or higher, or grade 3 ascites
- International Normalized Ratio (INR) of 1.5 or lower
- Ability to understand and comply with the trial procedures
You will not qualify if you...
- Treatment refractory or recurrent ascites at study inclusion
- Concomitant variceal bleeding meeting criteria for pre-emptive TIPS implantation
- Budd-Chiari syndrome
- Portal vein thrombosis
- Spontaneous bacterial peritonitis
- Uncontrolled systemic infection or sepsis causing ascites
- Cardiac cirrhosis or significant cardiac disease (NYHA class II or higher)
- Untreated moderate to severe valvular heart disease
- Grade III diastolic dysfunction by echocardiogram
- Left ventricular ejection fraction 50% or less
- Pulmonary hypertension with mean pulmonary arterial pressure over 45 mmHg
- Bilirubin greater than 3 mg/dl
- Obstructive cholestasis
- Hepatorenal syndrome type acute kidney injury
- Acute on chronic liver failure
- Benign liver tumor in the potential puncture area
- Previous liver transplantation
- Prior TIPS implantation
- Ongoing or recurrent hepatic encephalopathy grade higher than II
- Active tumors requiring treatment including hepatocellular carcinoma
- Recent antiviral treatment start for chronic hepatitis B within 3 months
- Untreated chronic hepatitis C infection
- Life expectancy less than 1 year
- Pregnant or breastfeeding women
- Lack of legal capacity to understand study
- Participation in other conflicting interventional trials
- Relationship of dependence or employment with trial sponsor or investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
Research Team
D
Dominik Bettinger, MD
CONTACT
M
Marco Janoschke, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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