Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychometric Hepatic Encephalopathy Score (PHES).
- Who it may be relevant to
- Registry conditions: Minimal Hepatic Encephalopathy. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Detection rate of minimal hepatic encephalopathy using PHES [Time frame: Baseline assessment]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Inclusion Criteria (Cirrhotic Patients):
- 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.
Inclusion Criteria (Healthy Controls):
<!-- -->
- Age 18-70 years.
- No chronic medical, neurological, psychiatric, renal, or cardiac disease.
- Able to read and write.
- Adequate cognition, hearing, vision, and physical ability.
Exclusion criteria
<!-- -->
- Chronic liver disease.
- Neuropsychiatric illness.
- Use of psychoactive medications.
- Illiteracy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07272707 · Soh-Med--25-11-9MS