Early TIPS in Patients With Liver Cirrhosis and Ascites

NCT06576934 | Recruiting DMC

• 1 other identifier: eTIPS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

liver cirrhosis; Transjugular intrahepatic portosystemic shunt; ascites; MELD

Outcome Measures

Primary Outcomes (1)

• Transplantation-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).

  Through study completion, an average of 12 months

Secondary Outcomes (4)

• Time to ascites with need for paracenteses

  Through study completion, an average of 12 months

• Assessment of quality of life

  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

  Through study completion, an average of 12 months

• Rate of TIPS dysfunction

  Through study completion, an average of 12 months

Study Arms (2)

Transjugular intrahepatic portosystemic shunt (TIPS)

EXPERIMENTAL

Patients will receive TIPS implantation if ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites occurs.

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Standard medical treatment

NO INTERVENTION

Patients in this group will receive standard medical treatment according to the current EASL guidelines (salt restriction, diuretic treatment, carvedilol, large-volume paracentesis if necessary, albumin substitution if more than 5 litre of ascites is removed)

Interventions

Transjugular intrahepatic portosystemic shunt (TIPS) PROCEDURE

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

Transjugular intrahepatic portosystemic shunt (TIPS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients eligible for this trial must not meet any of the following criteria:
• 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)
• Spontaneous bacterial peritonitis (SBP)
• 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)
• Clinical significant cardiac disease (NYHA ≥II)
• Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
• Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
• Reduced left ventricular ejection fraction ≤50%
• Pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg)
• Bilirubin \> 3 mg/dl
• Obstructive cholestasis
• Hepatorenal syndrome type AKI (HRS-AKI)

Sponsors & Collaborators

• University Hospital Muenster: collaborator
• Hannover Medical School: collaborator
• University of Leipzig: collaborator
• University Hospital, Aachen: collaborator
• University Hospital Lübeck: collaborator
• University Hospital, Bonn: collaborator
• University Hospital Munich: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University Hospital Freiburg: lead
• Jena University Hospital: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (1)

• Bettinger D, Janoschke M, Jenkner C, Kaufmann M, van Gessel J, Otter HH, Schultheiss M, Thimme R; on behalf of the eTIPS study group. Early implantation of a transjugular intrahepatic portosystemic shunt (TIPS) in patients with liver cirrhosis and ascites (eTIPS): a multicentre, randomised controlled trial. Trials. 2025 Oct 2;26(1):385. doi: 10.1186/s13063-025-09038-8.

  PMID: 41039580 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Ascites

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Central Study Contacts

Dominik Bettinger, MD

CONTACT

+4976127036870; dominik.bettinger@uniklinik-freiburg.de

Marco Janoschke, PhD

CONTACT

+4976127077831; marco.janoschke@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): February 15, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)