Early TIPS in Patients With Liver Cirrhosis and Ascites

Launched by UNIVERSITY HOSPITAL FREIBURG · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called TIPS, which stands for transjugular intrahepatic portosystemic shunt. It aims to see if this procedure is safer and more effective than standard treatments like diuretics (medications to help remove excess fluid) for patients with liver cirrhosis and ascites (fluid buildup in the abdomen). The goal of TIPS is to relieve pressure in the liver's blood vessels, which can help reduce the chances of developing ascites.

To be eligible for this trial, participants must be adults aged 18 to 80 with liver cirrhosis and ascites that is considered a first significant health issue. They should not have certain complications, like severe liver failure or active infections. If someone joins the trial, they can expect to receive either the TIPS procedure or the standard treatment, and they’ll be monitored closely for safety and effectiveness. This study is currently recruiting participants, so it could be a chance for patients to access new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients eligible for inclusion in this trial must meet all of the following criteria:
• • 1. Patients ≥ 18 years and \< 80 years
• • 2. Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
• • 3. Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
• • 4. INR ≤ 1.5
• • 5. Ability to understand the nature of the trial and the trial related procedures and to comply with them
• Exclusion Criteria:
• Patients eligible for this trial must not meet any of the following criteria:
• • 1. Treatment refractory or recurrent ascites at the time of study inclusion
• • 2. 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)
• • 3. Budd-Chiari syndrome
• • 4. Portal vein thrombosis (PVT)
• • 5. Spontaneous bacterial peritonitis (SBP)
• • 6. 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
• • 7. Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)
• • 8. Clinical significant cardiac disease (NYHA ≥II)
• • 9. Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
• • 10. Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
• • 11. Reduced left ventricular ejection fraction ≤50%
• • 12. Pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg)
• • 13. Bilirubin \> 3 mg/dl
• • 14. Obstructive cholestasis
• • 15. Hepatorenal syndrome type AKI (HRS-AKI)
• • 16. Acute on chronic liver failure
• • 17. Benign liver tumor within the potential puncture tract
• • 18. Patient after liver transplantation
• • 19. Prior TIPS implantation
• • 20. Ongoing and/or recurrent hepatic encephalopathy (grade \>II)
• • 21. Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
• • 22. New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
• • 23. Untreated chronic hepatitis C virus (HCV) infection
• • 24. Life expectancy \<1 year
• • 25. Pregnant or breastfeeding women
• • 26. Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
• • 27. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
• • 28. Person who is in a relationship of dependence/employment with the sponsor or the investigator