Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients (PHES-MHE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Minimal Hepatic Encephalopathy
• Intervention / Treatment: Other: Psychometric Hepatic Encephalopathy Score (PHES)

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sara Sabry, Resident doctor; Phone Number: 01005344254; Email: sara_sabry_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Cirrhotic Patients (Cases); Compensated cirrhotic patients aged 18-70 years undergoing Psychometric hepatic encephalopathy score testing.	Other: Psychometric Hepatic Encephalopathy Score (PHES); 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.
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.	Other: Psychometric Hepatic Encephalopathy Score (PHES); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of PHES subtest performance between cirrhotic patients and healthy controls	Differences in NCT-A, NCT-B, DST, SDT, and LTT scores between groups.	Baseline
Association between PHES total score and liver disease severity	Correlation of PHES with Child-Pugh score, ALT, AST, albumin, bilirubin, INR.	Baseline

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Minimal hepatic encephalopathy; Psychometric Hepatic Encephalopathy Score
• Other Study ID Numbers: Soh-Med--25-11-9MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data will be made available upon reasonable request.
• IPD Sharing Time Frame: 6 months after publication of study results.
• IPD Sharing Access Criteria: Data may be shared with investigators who submit a justified request via email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No