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Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients

Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07272707
Acronym
PHES-MHE
Enrollment
150
Registered
2025-12-09
Start date
2025-12-01
Completion date
2026-09-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Hepatic Encephalopathy

Keywords

Minimal hepatic encephalopathy, Psychometric Hepatic Encephalopathy Score

Brief 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. 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

OTHERPsychometric 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria (Cirrhotic Patients): 1. Age 18-70 years. 2. Diagnosed compensated liver cirrhosis, regardless of etiology. 3. Able to read and write. 4. Adequate vision, hearing, and physical ability to perform the PHES tests. Inclusion Criteria (Healthy Controls): <!-- --> 1. Age 18-70 years. 2. No chronic medical, neurological, psychiatric, renal, or cardiac disease. 3. Able to read and write. 4. Adequate cognition, hearing, vision, and physical ability.

Exclusion criteria

<!-- --> 1. Chronic liver disease. 2. Neuropsychiatric illness. 3. Use of psychoactive medications. 4. Illiteracy.

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of minimal hepatic encephalopathy using PHESBaseline assessmentProportion of compensated cirrhotic patients classified as having minimal hepatic encephalopathy based on PHES total score and normative regression equations.

Secondary

MeasureTime frameDescription
Comparison of PHES subtest performance between cirrhotic patients and healthy controlsBaselineDifferences in NCT-A, NCT-B, DST, SDT, and LTT scores between groups.
Association between PHES total score and liver disease severityBaselineCorrelation of PHES with Child-Pugh score, ALT, AST, albumin, bilirubin, INR.

Contacts

Primary ContactSara Sabry, Resident doctor
sara_sabry_post@med.sohag.edu.eg01005344254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026