Early TIPS for patients with liver cirrhosis and ascites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Medical Center Freiburg
  Freiburg im Breisgau, Germany Recruiting

Study contacts

• Study coordinator: Dominik Bettinger, MD
• Email: dominik.bettinger@uniklinik-freiburg.de
• Phone: +4976127036870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS

  A coil-assisted, small-diameter covered-stent technique is being tested to see if it can safely and effectively reduce shunt flow and lessen recurrent hepatic encephalopathy in people with a prior TIPS.

  Recruiting Air Force Military Medical University, China · Xi'an, Shaanxi · NCT07799948

• Austrian PBC Registry

  This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.

  Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

• Blood clotting and portal vein changes during TIPS placement in cirrhosis

  This project will see how blood clotting in the body and in the portal vein changes in adults with cirrhosis who are having a TIPS placed.

  Recruiting Assistance Publique - Hôpitaux de Paris · Villejuif · NCT07439939

• Underdilated stent technique to reduce encephalopathy after TIPS

  This trial tries to see if using an underdilated stent (smaller balloon dilation before placing a standard covered stent) during TIPS lowers the chance of hepatic encephalopathy for people with cirrhosis who need TIPS for variceal bleeding or refractory ascites.

  Recruiting at 2 sites The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality and 1 other locations · NCT07349654

• Handgrip strength and portal vein blood flow in people with liver cirrhosis

  This trial will test whether squeezing a handgrip changes portal vein and left gastric vein pressures and blood flow in adults with liver cirrhosis to see if muscle strength affects variceal hemodynamics.

  Recruiting at 2 sites Shanxi Provincial People's Hospital · Luoyang, Henan and 1 other locations · NCT07116096

• Using Ga-PSMA PET/MRI to assess liver cirrhosis

  This study is testing a new imaging method to see if it can help doctors better understand liver function and damage in people with liver cirrhosis.

  Recruiting Massachusetts General Hospital · Charlestown, Massachusetts · NCT06265272

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.