TIPS in Patients With Decompensated Liver Cirrhosis

Study Overview
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Brief Summary
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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).

Official Title
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Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis

Conditions
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Decompensated Liver Cirrhosis

Intervention / Treatment
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* Procedure: TIPS insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIPS insertion<br> | Procedure: TIPS insertion<br>* Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patients who die within 1 year | 1 year | 
| Occurrence of (Minimal) Hepatic Encephalopathy | Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT) | 1 year | 
| Change in Nutritional Status | Nutritional Status will be measured by hand grip strength (dynamometer) in kg | 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) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory markers (e.g. cytokine) | Different cytokines and markers of bacterial translocation (e.g. LPS) are measured | 12 months | 
| Change in different metabolites using mass spectroscopy (metabolomics measurements) | More than 300 metabolites will be measured | 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 | 12 months | 
| Analysis of stool samples | Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing) | 12 months | 
| Measurement of portal hypertension | Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal hypertension, TIPS, Refractory ascites, Variceal bleeding, Liver cirrhosis