Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
1 other identifier
observational
83
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2022
CompletedFirst Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedJuly 20, 2022
July 1, 2022
2.9 years
July 13, 2022
July 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE
12 months
Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE.
12 months
Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ)
12 months
Longitudinal assessment of cognitive function after TIPS insertion
12 months
Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE
12 months
- +1 more secondary outcomes
Eligibility Criteria
Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.
You may qualify if:
- 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
You may not qualify if:
- Contraindication against TIPS insertion
- Lack of consent
- History of liver transplantation
- Preemptive TIPS
- Emergency TIPS
- Severe neurological comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Department of Medicine I, University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562, Germany
Related Publications (1)
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.
PMID: 40751304DERIVED
Biospecimen
Peripheral blood (EDTA, serum). Portal vein blood (EDTA, serum). Hepatic vein blood (EDTA, serum).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Labenz, MD
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz. Dr. med.
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 20, 2022
Study Start
March 9, 2022
Primary Completion
February 10, 2025
Study Completion
February 10, 2025
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share