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Not Yet RecruitingNCT07272707

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERPsychometric 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.

Timeline

Start date
2025-12-01
Primary completion
2026-09-01
Completion
2026-09-01
First posted
2025-12-09
Last updated
2025-12-09

Source: ClinicalTrials.gov record NCT07272707. Inclusion in this directory is not an endorsement.