Early TIPS for 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
This study is testing if a procedure called TIPS can help people with liver cirrhosis and fluid buildup in their abdomen feel better compared to standard treatments like medications and draining the fluid.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital Freiburg Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT06576934 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation against standard treatments like diuretics and paracentesis in patients with liver cirrhosis and ascites. The study focuses on patients experiencing ascites as their first decompensating event. By creating a shunt between the liver vein and the portal vein, the trial seeks to reduce portal vein pressure and subsequently decrease the development of ascites. The goal is to analyze whether early TIPS implantation can provide better outcomes compared to traditional management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with liver cirrhosis and grade 2 or 3 ascites as their first decompensating event.
Not a fit: Patients with treatment refractory or recurrent ascites, or those experiencing variceal bleeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of ascites in patients with liver cirrhosis, potentially leading to better quality of life and reduced complications.
How similar studies have performed: Previous studies have indicated that early TIPS implantation can be beneficial in similar patient populations, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Freiburg im Breisgau
- University Medical Center Freiburg — Freiburg im Breisgau, Germany (Recruiting)
Study contacts
- Study coordinator: Dominik Bettinger, MD
- Email: dominik.bettinger@uniklinik-freiburg.de
- Phone: +4976127036870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.