Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.

Official Title
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Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis

Conditions
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Hepatic Encephalopathy, Liver Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis (clinical, sonographic, CT-morphological, laparoscopic or histological) TIPS indication: refractory ascites or secondary prophylaxis after variceal bleeding Age ≥ 18 years Ability to give consent Consent to the study after comprehensive information Exclusion Criteria: Contraindication against TIPS insertion Lack of consent History of liver transplantation Preemptive TIPS Emergency TIPS Severe neurological comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of post-TIPS HE using established tests | Evaluation of the predictive value of S-ANT1 and Stroop EncephalApp compared with PHES (gold standard) for predicting post-TIPS HE within the first 12 months after TIPS implantation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE | Evaluation of exploratory candidate inflammatory biomarkers derived from peripheral blood and analyzed using the validated Olink target 96 panel for the prediction ofpost-TIPS HE. | 12 months | 
| Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE. | The presence of frailty - using the validated LFI - will be assessed in each patient prior to TIPS implantation and 1, 3 and 6 months after TIPS implantation. The full range of the LFI is 1.0-7.0 (with a higher score indicating that the patient is more frail) | 12 months | 
| Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ) | Health-related quality will be assessed in each participant using the validated CLDQ. Quality of life will be assessed at baseline and 1-, 3- and 6- months post-TIPS implantation. | 12 months | 
| Longitudinal assessment of cognitive function after TIPS insertion | Assessment of longitudinal changes in PHES, Stroop EncephalApp and S-ANT1 after TIPS implantation. The tests will be applied to all patients at baseline and at 1-, 3- and 6- months post-TIPS implantation. | 12 months | 
| Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE | Evaluation of the usefulness of sNfL and GFAP for predicting post-TIPS HE during follow-up. sNfL and GFAP will be determined from blood obtained prior to TIPS implantation using a single molecule array (SiMoA technology). | 12 months | 
| Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI) | Sleep quality will be assessed in each participant using the validated PSQI. Sleep quality will be assessed at baseline and 1-, 3- and 6- months post-TIPS implantation. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis, Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt, TIPS, Post-TIPS Hepatic Encephalopathy, Post-TIPS HE, Minimal Hepatic Encephalopathy