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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466669
• Other study ID #: 20221
• Status: Recruiting
• Start date: March 9, 2022
• Est. completion date: February 10, 2025

Study information

• Verified date: July 2022
• Source: Johannes Gutenberg University Mainz
• Contact: Christian Labenz, MD
• Phone: +496131172830
• Email: Christian.Labenz[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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