Hepatic EncephalopathyNCT05466669
Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
An observational study of Hepatic Encephalopathy and Liver Cirrhosis, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis
- How many people
- 83 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Mar 2022to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.
Who may be able to join
- 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
Who cannot join
- Contraindication against TIPS insertion
- Lack of consent
- History of liver transplantation
- Preemptive TIPS
- Emergency TIPS
- Severe neurological comorbidities
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Medicine I, University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562
Jens Uwe Marquardt, Professor, +4945150044101, Jens.Marquardt@uksh.de
- Recruiting
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
Christian Labenz, MD, +496131172830, Christian.Labenz@unimedizin-mainz.de
Simon Johannes Gairing, MD, +496131176077, SimonJohannes.Gairing@unimedizin-mainz.de
About this study
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.
- 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
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start9 Mar 2022
- Primary completion10 Feb 2025 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Labenz, Johannes Gutenberg University Mainz
- Investigators
- Christian Labenz, MD, Principal investigator, Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466669
- Sponsor's protocol ID
- 20221
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40751304
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05466669
- Acronym / sponsor ID
- 20221
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication against TIPS insertion
- Lack of consent
- History of liver transplantation
- Preemptive TIPS
- Emergency TIPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of post-TIPS HE using established tests
Time frame: 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.
6 secondary outcomes
Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE
Time frame: 12 months
Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE.
Time frame: 12 months
Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ)
Time frame: 12 months
Longitudinal assessment of cognitive function after TIPS insertion
Time frame: 12 months
Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE
Time frame: 12 months
Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 40751304Kabelitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Labenz, MD principal investigator
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy and Liver Cirrhosis, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Labenz, MD (+496131172830, Christian.Labenz@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of post-TIPS HE using established tests (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.