Decompensated Liver Cirrhosis
Conditions
Keywords
Portal hypertension, TIPS, Refractory ascites, Variceal bleeding, Liver cirrhosis
Brief summary
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).
Interventions
PROCEDURETIPS insertion
Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Liver cirrhosis * Indication for TIPS insertion * Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School * Informed consent
Exclusion criteria
* Pregnancy or Lactation * Age \<18 years * Lack of Informed consent * Symptomatic anemia with Hb \<7g/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Patients who die within 1 year |
| Occurrence of (Minimal) Hepatic Encephalopathy | 1 year | Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT) |
| Change in Nutritional Status | 1 year | Nutritional Status will be measured by hand grip strength (dynamometer) in kg |
| Change in Quality of Life | 1 year | Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory markers (e.g. cytokine) | 12 months | Different cytokines and markers of bacterial translocation (e.g. LPS) are measured |
| Measurement of portal hypertension | 6 months | Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion |
| Change in different metabolites using mass spectroscopy (metabolomics measurements) | 12 months | More than 300 metabolites will be measured |
| Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs) | 12 months | Fluorescence activated cell sorting (FACS) analysis, genetics and in vitro stimulation assays will be performed |
| Analysis of stool samples | 12 months | Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing) |
Countries
Germany
Contacts
Primary ContactBenjamin Maasoumy, PD
Outcome results
None listed