Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 150
- Primary Endpoint
- Detection rate of minimal hepatic encephalopathy using PHES
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria (Cirrhotic Patients):
- •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.
- •Inclusion Criteria (Healthy Controls):
- •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.
Exclusion Criteria
- •Chronic liver disease.
- •Neuropsychiatric illness.
- •Use of psychoactive medications.
- •Illiteracy.
Outcomes
Primary Outcomes
Detection rate of minimal hepatic encephalopathy using PHES
Time Frame: Baseline assessment
Proportion of compensated cirrhotic patients classified as having minimal hepatic encephalopathy based on PHES total score and normative regression equations.
Secondary Outcomes
- Comparison of PHES subtest performance between cirrhotic patients and healthy controls(Baseline)
- Association between PHES total score and liver disease severity(Baseline)
Investigators
Sara Sabry Thabit
Sohag , Akhmim, Schools street
Sohag University