An observational study in Liver Cirrhosis, Portal Hypertension and Non-Cirrhotic Portal Hypertension, sponsored by University Hospital Freiburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Hospital Freiburg · Observational
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension
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
Transplantation-free survival
Time from study inclusion to death or liver transplantation
Time frame: 01/01/2023-31/12/2033
Time to development of post-TIPS hepatic encephalopathy
Time from study inclusion 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 from study inclusion to development of post-TIPS ACLF
Time frame: 01/01/2023-31/12/2033
Time to need for TIPS revision
Time from study inclusion to need for TIPS revision
Time frame: 01/01/2023-31/12/2033
Prevalence of osteoporosis in patients with TIPS implantation
Osteoporosis is assessed by DXA measurement
Time frame: 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.
Time frame: 01/01/2023-31/12/2033
Prevalence of sarcopenia in patients with TIPS implantation
Sarcopenia is assessed by computed tomography.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 01/01/2023-31/12/2033
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Dec 2033, 131 months after the start.
Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 131 months is above that.
Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Freiburg