Early TIPS in Patients With Liver Cirrhosis and Ascites (NCT06576934) | Clinical Trial Compass
RecruitingNot Applicable
Early TIPS in Patients With Liver Cirrhosis and Ascites
Germany134 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients ≥ 18 years and \< 80 years
✓. Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
✓. Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
✓. INR ≤ 1.5
✓. Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion criteria
✕. Treatment refractory or recurrent ascites at the time of study inclusion
✕. 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)
✕. Budd-Chiari syndrome
✕. Portal vein thrombosis (PVT)
What they're measuring
1
Transplantation-free survival (TFS)
Timeframe: Through study completion, an average of 12 months
✕. 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
✕. Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)