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NCT Number: NCT07272707

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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):

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  • 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

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  • Chronic liver disease.
  • Neuropsychiatric illness.
  • Use of psychoactive medications.
  • Illiteracy.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of PHES subtest performance between cirrhotic patients and healthy controls

    Time frame: Baseline

    Differences in NCT-A, NCT-B, DST, SDT, and LTT scores between groups.

  2. Association between PHES total score and liver disease severity

    Time frame: Baseline

    Correlation of PHES with Child-Pugh score, ALT, AST, albumin, bilirubin, INR.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Sabry, Resident doctor

CONTACT

[email protected]

01005344254

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Acronym: PHES-MHE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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