An observational study in Decompensated Liver Cirrhosis, sponsored by Hannover Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Hannover Medical School · Observational
This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).
375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 135 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: TIPS insertion
Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.
Mortality
Patients who die within 1 year
Time frame: 1 year
Occurrence of (Minimal) Hepatic Encephalopathy
Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)
Time frame: 1 year
Change in Nutritional Status
Nutritional Status will be measured by hand grip strength (dynamometer) in kg
Time frame: 1 year
Change in Quality of Life
Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)
Time frame: 1 year
Change in inflammatory markers (e.g. cytokine)
Different cytokines and markers of bacterial translocation (e.g. LPS) are measured
Time frame: 12 months
Change in different metabolites using mass spectroscopy (metabolomics measurements)
More than 300 metabolites will be measured
Time frame: 12 months
Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)
Fluorescence activated cell sorting (FACS) analysis, genetics and in vitro stimulation assays will be performed
Time frame: 12 months
Analysis of stool samples
Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)
Time frame: 12 months
Measurement of portal hypertension
Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion
Time frame: 6 months
Started Aug 2019 (actual). Primary completion is estimated for Dec 2027, 100 months after the start.
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.
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