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

Recruiting

• Conditions: Hepatic Encephalopathy; Liver Cirrhosis

• Registration Number: NCT05466669
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Status Verified: 2022-07
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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)
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.
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.
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).

Trial Locations

Locations (2)

Department of Medicine I, University Hospital Schleswig-Holstein; 🇩🇪 Luebeck, Schleswig-Holstein, Germany

Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany