Early TIPS in Patients With Liver Cirrhosis and Ascites

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.

Conditions

• Liver Cirrhosis
• Ascites Hepatic
• Portal Hypertension

Interventions

PROCEDURE

Transjugular intrahepatic portosystemic shunt (TIPS)

TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.

Sponsors & Collaborators

• Jena University Hospital

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• University Hospital Munich

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• University Hospital Lübeck

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University Hospital Freiburg

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2029-01-15

Completion

2029-02-15

Countries

• Germany

Study Locations