New shunt procedure could extend life for liver patients
NCT ID NCT06576934
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares early placement of a TIPS (a small tube that reroutes blood flow in the liver) against standard treatments like diuretics and fluid drainage in 134 patients with liver cirrhosis and ascites (fluid buildup). The goal is to see if TIPS improves survival and reduces the need for repeated fluid removal. Participants are adults aged 18-79 with specific severity of ascites and liver function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transjugular intrahepatic portosystemic shunt (TIPS) procedure
- What this could lead to
- If successful, early TIPS could offer a better way to manage ascites and improve survival in liver cirrhosis patients.
- What could go wrong
- This is a mid-stage trial with 134 participants, so results may not apply to all patients. TIPS carries risks like infection or shunt blockage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Medical Center Freiburg
RECRUITINGFreiburg im Breisgau, 79106, Germany
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