Freiburg TIPS Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS).
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension, Budd Chiari Syndrome. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Transplantation-free survival [Time frame: 01/01/2023-31/12/2033]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Exclusion criteria
- Withdrawal of written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center Freiburg, Department of Medicine II — Freiburg im Breisgau
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. PMID 41204773
Identifiers
NCT: NCT05782556 · FRETIR01