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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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Labenz, MD | Contact | +496131172830 | Christian.Labenz@unimedizin-mainz.de | |
| Simon Johannes Gairing, MD | Contact | +496131176077 | SimonJohannes.Gairing@unimedizin-mainz.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Labenz, MD | Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40751304 | Derived | Kabelitz MA, Gairing SJ, Tiede A, Schleicher EM, Ahl LG, Wagner L, Zucker-Reimann F, Rieland H, Mauz JB, Weinmann-Menke J, Meyer BC, Pitton MB, Wedemeyer H, Galle PR, Sandmann L, Maasoumy B, Labenz C. Impact of Frailty on the Prognosis of Patients With Liver Cirrhosis Undergoing Insertion of a TIPS. Aliment Pharmacol Ther. 2026 Jan;63(1):109-118. doi: 10.1111/apt.70315. Epub 2025 Aug 1. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Peripheral blood (EDTA, serum). Portal vein blood (EDTA, serum). Hepatic vein blood (EDTA, serum).
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 |
| Department of Medicine I, University Hospital Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23562 | Germany |
|
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |