Clinical trial NCT05466669: Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
Official title: Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
Keywords: Liver Cirrhosis
Hepatic Encephalopathy
Transjugular Intrahepatic Portosystemic Shunt
TIPS
Post-TIPS Hepatic Encephalopathy
Post-TIPS HE
Minimal Hepatic Encephalopathy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prediction of post-TIPS HE using established tests
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE
timeFrame: 12 months
measure: Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE.
timeFrame: 12 months
measure: Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: 12 months
measure: Longitudinal assessment of cognitive function after TIPS insertion
timeFrame: 12 months
measure: Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE
timeFrame: 12 months
measure: Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
state: Rhineland-Palatinate
city: Luebeck
country: Germany
facility: Department of Medicine I, University Hospital Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
name: Christian Labenz, MD
role: PRINCIPAL_INVESTIGATOR
References: