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

NCT07272707 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med--25-11-9MS
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Minimal Hepatic Encephalopathy

Keywords

Minimal hepatic encephalopathy; Psychometric Hepatic Encephalopathy Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of PHES subtest performance between cirrhotic patients and healthy controls

  Baseline

• Association between PHES total score and liver disease severity

  Baseline

Study Arms (2)

Group 1: Cirrhotic Patients (Cases)

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

Other: Psychometric Hepatic Encephalopathy Score (PHES)

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)

Interventions

Psychometric Hepatic Encephalopathy Score (PHES) 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); Group 2: Healthy Volunteers (Controls)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
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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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

Sara Sabry, Resident doctor

CONTACT

01005344254; sara_sabry_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sohag , Akhmim, Schools street

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication of study results.
• Access Criteria: Data may be shared with investigators who submit a justified request via email.