Early TIPS in Patients With Liver Cirrhosis and Ascites

NCT ID: NCT06576934

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-02-15

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.

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.

Conditions

Liver Cirrhosis; Ascites Hepatic; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transjugular intrahepatic portosystemic shunt (TIPS)

Intervention Type: PROCEDURE

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

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: collaborator

University Hospital Munich (LMU)

UNKNOWN

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

University Hospital, Aachen

OTHER

Sponsor Role: collaborator

University Hospital Lübeck

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Dominik Bettinger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Freiburg

Freiburg im Breisgau, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dominik Bettinger, MD

Role: CONTACT

dominik.bettinger@uniklinik-freiburg.de

+4976127036870

Marco Janoschke, PhD

Role: CONTACT

marco.janoschke@uniklinik-freiburg.de

+4976127077831

Facility Contacts

Dominik Bettinger, Prof. Dr.

Role: primary

dominik.bettinger@uniklinik-freiburg.de

+4976127036870

References

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.

Reference Type: DERIVED

PMID: 41039580 (View on PubMed)

Other Identifiers

eTIPS

Identifier Type: -

Identifier Source: org_study_id