Liver CirrhosiseTIPSNCT06576934
Early TIPS in Patients With Liver Cirrhosis and Ascites
A study testing Transjugular intrahepatic portosystemic shunt (TIPS) in people with Liver Cirrhosis and Ascites Hepatic, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Ascites Hepatic, Portal Hypertension
- What is being tested?
- Transjugular intrahepatic portosystemic shunt (TIPS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2025to 15 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this trial must meet all of the following criteria:
- 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
Who cannot join
- Patients eligible for this trial must not meet any of the following criteria:
- Treatment refractory or recurrent ascites at the time of study inclusion
- 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)
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- 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)
- Acute on chronic liver failure
- Benign liver tumor within the potential puncture tract
- Patient after liver transplantation
- Prior TIPS implantation
- Ongoing and/or recurrent hepatic encephalopathy (grade >II)
- Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
- New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
- Untreated chronic hepatitis C virus (HCV) infection
- Life expectancy <1 year
- Pregnant or breastfeeding women
- Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Freiburg
Freiburg im Breisgau, 79106
Dominik Bettinger, Prof. Dr., +4976127036870, dominik.bettinger@uniklinik-freiburg.de
About this study
Official title: 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.
Read the 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
- Being tested
- Transjugular intrahepatic portosystemic shunt (TIPS)
- Keywords
- liver cirrhosis, Transjugular intrahepatic portosystemic shunt, ascites, MELD
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shunt (TIPS)Procedure or surgery
TIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 months
Rate of TIPS dysfunction
Development of TIPS dysfunction in the TIPS group
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Apr 2025
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital, Johannes Gutenberg University Mainz, University Hospital Muenster, University Hospital, Bonn, University Hospital Munich, Hannover Medical School, University of Leipzig, University Hospital, Aachen, University Hospital Lübeck, Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Prof. Dr. Dominik Bettinger, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576934
- Sponsor's protocol ID
- eTIPS
- Acronym
- eTIPS
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41039580
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06576934
- Acronym / sponsor ID
- eTIPS / eTIPS
- Conditions
- Liver Cirrhosis, Ascites Hepatic, Portal Hypertension
- Keywords
- liver cirrhosis, Transjugular intrahepatic portosystemic shunt, ascites, MELD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Jena University Hospital, Johannes Gutenberg University Mainz, University Hospital Muenster, University Hospital, Bonn, University Hospital Munich, Hannover Medical School, University of Leipzig, University Hospital, Aachen, University Hospital Lübeck, Heinrich-Heine University, Duesseldorf
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transjugular intrahepatic portosystemic shunt (TIPS) | Experimental | Procedure: 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. |
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (29 listed)
- Treatment refractory or recurrent ascites at the time of study inclusion
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Transjugular intrahepatic portosystemic shunt (TIPS) |
Primary outcome
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).
4 secondary outcomes
Time to ascites with need for paracenteses
Time frame: 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
Rate of TIPS implantation in the standard medical treatment group
Time frame: Through study completion, an average of 12 months
Rate of TIPS dysfunction
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41039580Bettinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular intrahepatic portosystemic shunt (TIPS) in people with Liver Cirrhosis and Ascites Hepatic, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik Bettinger, MD (+4976127036870, dominik.bettinger@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplantation-free survival (TFS) (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.