RecruitingNot ApplicableNCT06576934

Early TIPS in 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

Sponsor

University Hospital Freiburg

Enrollment

134 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhosis Portal Hypertension Ascites Hepatic

Summary

The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event. By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a small tube in the liver (called a TIPS procedure — transjugular intrahepatic portosystemic shunt) early in the course of cirrhosis-related fluid buildup (ascites) can prevent serious complications like repeat hospitalizations or kidney failure. **You may be eligible if...** - You are between 18 and 80 years old - You have liver cirrhosis (confirmed by biopsy or clinical features) - You are experiencing significant fluid buildup in the abdomen (ascites) as your first major complication of cirrhosis - Your blood clotting is not too impaired (INR ≤ 1.5) **You may NOT be eligible if...** - You have already had other complications like bleeding or encephalopathy (confusion from liver disease) - You have heart failure or severe lung disease - You have an active infection or cancer in the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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