Liver CirrhosisFRETIRNCT05782556
Freiburg TIPS Registry
An observational study of Liver Cirrhosis and Portal Hypertension, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension
- What is being tested?
- Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 30 Jun 2034
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension will be included in this study.In summary, patients with the folowing conditions can be included: * liver cirrhosis and indication for TIPS implantation (pre-emptive TIPS or rescue TIPS in case of varical bleeding, secondary prophylaxis of varical bleeding, recurrent or refractory ascites, TIPS before surgery) * non-cirrhotic portal vein thrombosis * Budd-Chiari syndrome * porto-sinusoidal vascular disease
Who may be able to join
- Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Who cannot join
- Withdrawal of written informed consent
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, Department of Medicine II
Freiburg im Breisgau, 79106
Dominik Bettinger, MD, 49761270-36870, dominik.bettinger@uniklinik-freiburg.de
Dominik Bettinger, MD
About this study
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.
Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.
Read the detailed description
Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.
Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.
All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.
Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.
- Conditions
- Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension, Budd Chiari Syndrome, Portal Vein Thrombosis, Portal Systemic Shunt
- Being tested
- Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
- Keywords
- Liver cirhosis, Transjugular intrahepatic portosystemic shunt, Non-Cirrhotic Portal Hypertension, Prognosis, Outcome
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Budd-Chiari Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)Device
For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient
| Study group | Role | What they receive |
|---|---|---|
| Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) | Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension Receives: Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplantation-free survival
Time from study inclusion to death or liver transplantation
Measured: 01/01/2023-31/12/2033
Secondary outcomes (9)
Time to development of post-TIPS hepatic encephalopathy
Time from study inclusion to development of post-TIPS hepatic encephalopathy
Measured: 01/01/2023-31/12/2033
Time to development of post-TIPS acute- on chronic liver failure (ACLF)
Time from study inclusion to development of post-TIPS ACLF
Measured: 01/01/2023-31/12/2033
Time to need for TIPS revision
Time from study inclusion to need for TIPS revision
Measured: 01/01/2023-31/12/2033
Prevalence of osteoporosis in patients with TIPS implantation
Osteoporosis is assessed by DXA measurement
Measured: 01/01/2023-31/12/2033
Impact of osteoporosis on prognosis and decompensating events after TIPS
Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events.
Measured: 01/01/2023-31/12/2033
Prevalence of sarcopenia in patients with TIPS implantation
Sarcopenia is assessed by computed tomography.
Measured: 01/01/2023-31/12/2033
Impact of sarcopenia on prognosis and decompensating events after TIPS
Sarcopenia is assessed by computed tomography and is correlated with prognosis and the development of decompensating events after TIPS
Measured: 01/01/2023-31/12/2033
Time to development of post-TIPS infections/sepsis
Time from study inclusion to development of post-TIPS infections/sepsis
Measured: 01/01/2023-31/12/2033
Periinterventional complications
Periinterventional complications (infections, bleeding, biliary injury) are assessed during the intervention. These complications are documented in the report of the intervention and are assessed systematically.
Measured: 01/01/2023-31/12/2033
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2033 (estimated)
- Study completion30 Jun 2034 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dominik Bettinger, University Hospital Freiburg
- Investigators
- Dominik Bettinger, MD, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782556
- Sponsor's protocol ID
- FRETIR01
- Acronym
- FRETIR
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.
PubMed 41204773
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
- Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
- ClinicalTrials.gov ID
- NCT05782556
- Acronym / sponsor ID
- FRETIR / FRETIR01
- Conditions
- Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension, Budd Chiari Syndrome, Portal Vein Thrombosis, Portal Systemic Shunt
- Keywords
- Liver cirhosis, Transjugular intrahepatic portosystemic shunt, Non-Cirrhotic Portal Hypertension, Prognosis, Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 23 Mar 2023 (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.
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.
Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.
Detailed description
Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.
Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.
All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.
Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) | – | Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension will be included in this study.In summary, patients with the folowing conditions can be included: * liver cirrhosis and indication for TIPS implantation (pre-emptive TIPS or rescue TIPS in case of varical bleeding, secondary prophylaxis of varical bleeding, recurrent or refractory ascites, TIPS before surgery) * non-cirrhotic portal vein thrombosis * Budd-Chiari syndrome * porto-sinusoidal vascular disease
Key inclusion criteria (1 listed)
- Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Key exclusion criteria (1 listed)
- Withdrawal of written informed consent
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 |
|---|---|---|
| Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient | Device | Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) |
Primary outcome
Transplantation-free survival
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to death or liver transplantation
9 secondary outcomes
Time to development of post-TIPS hepatic encephalopathy
Time frame: 01/01/2023-31/12/2033
Time to development of post-TIPS acute- on chronic liver failure (ACLF)
Time frame: 01/01/2023-31/12/2033
Time to need for TIPS revision
Time frame: 01/01/2023-31/12/2033
Prevalence of osteoporosis in patients with TIPS implantation
Time frame: 01/01/2023-31/12/2033
Impact of osteoporosis on prognosis and decompensating events after TIPS
Time frame: 01/01/2023-31/12/2033
Prevalence of sarcopenia in patients with TIPS implantation
Time frame: 01/01/2023-31/12/2033
Impact of sarcopenia on prognosis and decompensating events after TIPS
Time frame: 01/01/2023-31/12/2033
Time to development of post-TIPS infections/sepsis
Time frame: 01/01/2023-31/12/2033
Periinterventional complications
Time frame: 01/01/2023-31/12/2033
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 41204773Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.
- Homepage Interventional Hepatology University Medical Center FreiburgLink provided by the sponsor.
- 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.
Dominik Bettinger, MD principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Portal Hypertension, 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 1 inclusion and 1 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 (49761270-36870, 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 (time frame: 01/01/2023-31/12/2033). 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 NCT05782556, 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.