Hepatic Encephalopathy, Liver Cirrhosis
Conditions
Keywords
Liver Cirrhosis, Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt, TIPS, Post-TIPS Hepatic Encephalopathy, Post-TIPS HE, Minimal Hepatic Encephalopathy
Brief summary
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.
Interventions
None listed
Sponsors
Johannes Gutenberg University Mainz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of post-TIPS HE using established tests | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE. | 12 months | 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) |
| Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ) | 12 months | 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. |
| Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE | 12 months | 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. |
| Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE | 12 months | 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). |
| Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI) | 12 months | 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. |
| Longitudinal assessment of cognitive function after TIPS insertion | 12 months | 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. |
Countries
Germany
Contacts
Primary ContactChristian Labenz, MD
Backup ContactSimon Johannes Gairing, MD
Outcome results
None listed