Early TIPS in Patients With Liver Cirrhosis and Ascites

Prior treatment

• 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

Other illness

• 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

Lab values

• 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

Other

• 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

• 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