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

N/ANot Yet RecruitingNCT07272707

Sohag University150 enrolled

Overview

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.

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

150

Conditions

Minimal Hepatic Encephalopathy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline assessment

Secondary Outcomes

Comparison of PHES subtest performance between cirrhotic patients and healthy controls

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

Time frame: Baseline

Association between PHES total score and liver disease severity

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