Minimal Hepatic EncephalopathyPHES-MHENCT07272707
Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients
An observational study of Minimal Hepatic Encephalopathy, run by Sohag University.
Trial summary
Minimal hepatic encephalopathy (MHE) is a covert form of hepatic encephalopathy associated with cognitive and psychomotor impairment in patients with compensated liver cirrhosis. Early detection of MHE is crucial to prevent progression to overt encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Psychometric Hepatic Encephalopathy Score (PHES)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Cirrhotic Patients (Cases) Compensated cirrhotic patients aged 18-70 years undergoing PHES testing. Group 2: Healthy Volunteers (Controls) Healthy adults aged 18-70 years with no chronic disease and normal cognitive function.
Who may be able to join
- Age 18-70 years.
- Diagnosed compensated liver cirrhosis, regardless of etiology.
- Able to read and write.
- Adequate vision, hearing, and physical ability to perform the PHES tests.
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- Age 18-70 years.
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- No chronic medical, neurological, psychiatric, renal, or cardiac disease.
- Able to read and write.
- Adequate cognition, hearing, vision, and physical ability.
Who cannot join
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- Chronic liver disease.
- Neuropsychiatric illness.
- Use of psychoactive medications.
- Illiteracy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Minimal hepatic encephalopathy (MHE) is a covert form of hepatic encephalopathy associated with cognitive and psychomotor impairment in patients with compensated liver cirrhosis. Early detection of MHE is crucial to prevent progression to overt encephalopathy. The Psychometric Hepatic Encephalopathy Score (PHES) is a validated neuropsychological test battery for diagnosing MHE. This study aims to screen for MHE among compensated cirrhotic patients using PHES and to compare performance with healthy matched controls.
Read the detailed description
This cross-sectional case-control study will include compensated cirrhotic patients aged 18-70 years attending Sohag University Hospital, as well as a control group of healthy volunteers matched for age and education. All participants will undergo clinical evaluation, laboratory investigations, abdominal ultrasound, and psychometric assessment using the PHES battery (NCT-A, NCT-B, DST, SDT, LTT). PHES performance will be compared between cases and controls. The diagnostic accuracy of PHES for detecting MHE will be evaluated using sensitivity, specificity, PPV, NPV, and AUROC. Correlation analyses will explore associations between PHES scores and liver disease severity.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Psychometric Hepatic Encephalopathy Score (PHES)
- Keywords
- Minimal hepatic encephalopathy, Psychometric Hepatic Encephalopathy Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric Hepatic Encephalopathy Score (PHES)Other
A standardized paper-and-pencil neuropsychological test battery used to detect minimal hepatic encephalopathy. It includes:
- Number Connection Test A (NCT-A)
- Number Connection Test B (NCT-B)
- Digit Symbol Test (DST)
- Serial Dotting Test (SDT)
- Line Tracing Test (LTT)
Tests are administered in a quiet environment between 8 AM and 3 PM by trained personnel. Performance is recorded as completion time, error score, or point score depending on test type.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cirrhotic Patients (Cases) | Compensated cirrhotic patients aged 18-70 years undergoing Psychometric hepatic encephalopathy score testing. Receives: Other: Psychometric Hepatic Encephalopathy Score (PHES) | |
| Group 2: Healthy Volunteers (Controls) | Healthy adults aged 18-70 years with no chronic disease and normal cognitive function undergoing Psychometric hepatic encephalopathy score testing. Receives: Other: Psychometric Hepatic Encephalopathy Score (PHES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of minimal hepatic encephalopathy using PHES
Proportion of compensated cirrhotic patients classified as having minimal hepatic encephalopathy based on PHES total score and normative regression equations.
Measured: Baseline assessment
Secondary outcomes (2)
Comparison of PHES subtest performance between cirrhotic patients and healthy controls
Differences in NCT-A, NCT-B, DST, SDT, and LTT scores between groups.
Measured: Baseline
Association between PHES total score and liver disease severity
Correlation of PHES with Child-Pugh score, ALT, AST, albumin, bilirubin, INR.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Sabry Thabit, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272707
- Sponsor's protocol ID
- Soh-Med--25-11-9MS
- Acronym
- PHES-MHE
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT07272707
- Acronym / sponsor ID
- PHES-MHE / Soh-Med--25-11-9MS
- Conditions
- Minimal Hepatic Encephalopathy
- Keywords
- Minimal hepatic encephalopathy, Psychometric Hepatic Encephalopathy Score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Dec 2025 (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.
Minimal hepatic encephalopathy (MHE) is a covert form of hepatic encephalopathy associated with cognitive and psychomotor impairment in patients with compensated liver cirrhosis. Early detection of MHE is crucial to prevent progression to overt encephalopathy. The Psychometric Hepatic Encephalopathy Score (PHES) is a validated neuropsychological test battery for diagnosing MHE. This study aims to screen for MHE among compensated cirrhotic patients using PHES and to compare performance with healthy matched controls.
Detailed description
This cross-sectional case-control study will include compensated cirrhotic patients aged 18-70 years attending Sohag University Hospital, as well as a control group of healthy volunteers matched for age and education. All participants will undergo clinical evaluation, laboratory investigations, abdominal ultrasound, and psychometric assessment using the PHES battery (NCT-A, NCT-B, DST, SDT, LTT). PHES performance will be compared between cases and controls. The diagnostic accuracy of PHES for detecting MHE will be evaluated using sensitivity, specificity, PPV, NPV, and AUROC. Correlation analyses will explore associations between PHES scores and liver disease severity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cirrhotic Patients (Cases) | – | Other: Psychometric Hepatic Encephalopathy Score (PHES)Compensated cirrhotic patients aged 18-70 years undergoing Psychometric hepatic encephalopathy score testing. |
| Group 2: Healthy Volunteers (Controls) | – | Other: Psychometric Hepatic Encephalopathy Score (PHES)Healthy adults aged 18-70 years with no chronic disease and normal cognitive function undergoing Psychometric hepatic encephalopathy score testing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Cirrhotic Patients (Cases) Compensated cirrhotic patients aged 18-70 years undergoing PHES testing. Group 2: Healthy Volunteers (Controls) Healthy adults aged 18-70 years with no chronic disease and normal cognitive function.
Key inclusion criteria (9 listed)
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Key exclusion criteria (5 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychometric Hepatic Encephalopathy Score (PHES)A standardized paper-and-pencil neuropsychological test battery used to detect minimal hepatic encephalopathy. It includes: 1. Number Connection Test A (NCT-A) 2. Number Connection Test B (NCT-B) 3. Digit Symbol Test (DST) 4. Serial Dotting Test (SDT) 5. Line Tracing Test (LTT) Tests are administered in a quiet environment between 8 AM and 3 PM by trained personnel. Performance is recorded as completion time, error score, or point score depending on test type. | Other | Group 1: Cirrhotic Patients (Cases), Group 2: Healthy Volunteers (Controls) |
Primary outcome
Detection rate of minimal hepatic encephalopathy using PHES
Time frame: Baseline assessment
Proportion of compensated cirrhotic patients classified as having minimal hepatic encephalopathy based on PHES total score and normative regression equations.
2 secondary outcomes
Comparison of PHES subtest performance between cirrhotic patients and healthy controls
Time frame: Baseline
Association between PHES total score and liver disease severity
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available upon reasonable request.
Related trials for Minimal Hepatic Encephalopathy
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Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Hepatic Encephalopathy, run by Sohag University.
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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Sabry, Resident doctor (01005344254, sara_sabry_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of minimal hepatic encephalopathy using PHES (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.