Early implantation of a transjugular intrahepatic portosystemic shunt (TIPS) in patients with liver cirrhosis and ascites (eTIPS): a multicentre, randomised controlled trial

Background: Portal hypertension is a major complication in patients with liver cirrhosis, leading to severe outcomes such as variceal bleeding and ascites. Transjugular intrahepatic portosystemic shunt (TIPS) has emerged as an effective interventional treatment of recurrent ascites and variceal bleeding. However, up to 30% of patients with recurrent ascites show TIPS refractory ascites, and prior data have shown that the frequency of paracenteses before TIPS implantation predicts ascites clearance indicating that TIPS implantation may be too late in some patients. Especially, patients with grade 2 ascites and a MELD score ≥ 15, or grade 3 ascites irrespective of MELD score at first decompensation with ascites face a high risk of further decompensation and mortality. Therefore, these patients may benefit from early TIPS implantation in order to improve post-TIPS mortality. We hypothesise that early TIPS implantation in these selected patients at the time of the first decompensation may improve transplantation-free survival compared to standard medical treatment (SMT). Methods: The eTIPS study is a prospective, randomised, open, multicenter interventional, superiority trial. Patients will be randomised 1:1 in the intervention group with TIPS implantation and in the SMT group. The primary endpoint is transplantation-free survival. Secondary endpoints include the time to ascites with need for paracentesis and quality of life assessed six and 12 months after randomisation. Discussion: Expanding the concept of early TIPS implantation to ascites management may offer significant survival benefits and may significantly change the treatment algorithm of patients with ascites. Trial registration: German Registry for Clinical Studies DRKS00034545. Registered on 20/02/2025. Clinical trials NCT06576934. Registered on 04/12/2024.