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

NCT ID: NCT07272707

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-09-01

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.

Conditions

Minimal Hepatic Encephalopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Psychometric Hepatic Encephalopathy Score (PHES)

Intervention Type: OTHER

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.

Group 1: Cirrhotic Patients (Cases)

Compensated cirrhotic patients aged 18-70 years undergoing Psychometric hepatic encephalopathy score testing.

Psychometric Hepatic Encephalopathy Score (PHES)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

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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

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1. Chronic liver disease.

2. Neuropsychiatric illness.

3. Use of psychoactive medications.

4. Illiteracy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sara Sabry Thabit

Sohag , Akhmim, Schools street

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sara Sabry, Resident doctor

Role: CONTACT

sara_sabry_post@med.sohag.edu.eg

01005344254

Other Identifiers

Soh-Med--25-11-9MS

Identifier Type: -

Identifier Source: org_study_id