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.
Complications in patients with liver cirrhosis are mainly due to the development of clinical significant portal hypertension. These complications include development of varices and ascites. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) has emerged as a safe and effective interventional treatment of portal hypertension. TIPS implantation is recommended for secondary prophylaxis of variceal bleeding. Further, in patients with acute variceal bleeding, early TIPS implantation within 72 hours after the bleeding episode is associated with a lower re-bleeding rate and also improved survival in high risk patients. In patients with ascites, TIPS implantation is recommend in more advanced stages when conservative treatment has failed to control ascites. Importantly, ascites clearance can be achieved in only 51% in these patients. Recently, it has been shown that patients with a lower paracenteses frequency have a higher chance of ascites control compared to patients with long-term paracenteses. These data suggest that TIPS implantation in patients with ascites should not be delayed comparable to patients with acute variceal bleeding. The presented study aims to analyse the concept of early TIPS implantation in patients with liver cirrhosis and ascites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.
University Medical Center Freiburg
Freiburg im Breisgau, Germany
RECRUITINGTransplantation-free survival (TFS)
The primary objective of this study is to assess a survival benefit in patients with early allocation to TIPS implantation in comparison to patients with standard medical treatment (SMT).
Time frame: Through study completion, an average of 12 months
Time to ascites with need for paracenteses
Assessment of the duration until the next paracentesis after randomisation occurs to compare the efficacy of TIPS implantation compared to standard medical treatment.
Time frame: Through study completion, an average of 12 months
Assessment of quality of life
Quality of life assessed with the SF-36 and CLDQ (chronic liver disease questionnaire) before TIPS implantation/study inclusion, 6 and 12 months after randomisation.
Time frame: Through study completion, an average of 1 year: at study inclusion, at 6 and 12 months after randomisation
Rate of TIPS implantation in the standard medical treatment group
Need for TIPS implantation (recurrent ascites or variceal bleeding) in the standard medical treatment group.
Time frame: Through study completion, an average of 12 months
Rate of TIPS dysfunction
Development of TIPS dysfunction in the TIPS group
Time frame: Through study completion, an average of 12 months
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