Early TIPS in Patients With Liver Cirrhosis and Ascites (eTIPS)

April 27, 2026 updated by: Prof. Dr. Dominik Bettinger, University Hospital Freiburg

Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients eligible for inclusion in this trial must meet all of the following criteria:

  1. Patients ≥ 18 years and < 80 years
  2. Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
  3. Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
  4. INR ≤ 1.5
  5. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion Criteria:

Patients eligible for this trial must not meet any of the following criteria:

  1. Treatment refractory or recurrent ascites at the time of study inclusion
  2. 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)
  3. Budd-Chiari syndrome
  4. Portal vein thrombosis (PVT)
  5. Spontaneous bacterial peritonitis (SBP)
  6. 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
  7. Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)
  8. Clinical significant cardiac disease (NYHA ≥II)
  9. Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
  10. Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
  11. Reduced left ventricular ejection fraction ≤50%
  12. Pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg)
  13. Bilirubin > 3 mg/dl
  14. Obstructive cholestasis
  15. Hepatorenal syndrome type AKI (HRS-AKI)
  16. Acute on chronic liver failure
  17. Benign liver tumor within the potential puncture tract
  18. Patient after liver transplantation
  19. Prior TIPS implantation
  20. Ongoing and/or recurrent hepatic encephalopathy (grade >II)
  21. Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
  22. New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
  23. Untreated chronic hepatitis C virus (HCV) infection
  24. Life expectancy <1 year
  25. Pregnant or breastfeeding women
  26. Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
  27. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
  28. Person who is in a relationship of dependence/employment with the sponsor or the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transjugular intrahepatic portosystemic shunt (TIPS)
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)
TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.
No Intervention: Standard medical treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplantation-free survival (TFS)
Time Frame: Through study completion, an average of 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ascites with need for paracenteses
Time Frame: Through study completion, an average of 12 months
Assessment of the duration until the next paracentesis after randomisation occurs to compare the efficacy of TIPS implantation compared to standard medical treatment.
Through study completion, an average of 12 months
Assessment of quality of life
Time Frame: Through study completion, an average of 1 year: at study inclusion, at 6 and 12 months after randomisation
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.
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
Time Frame: Through study completion, an average of 12 months
Need for TIPS implantation (recurrent ascites or variceal bleeding) in the standard medical treatment group.
Through study completion, an average of 12 months
Rate of TIPS dysfunction
Time Frame: Through study completion, an average of 12 months
Development of TIPS dysfunction in the TIPS group
Through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

February 15, 2029

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eTIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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