Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients (PHES-MHE)

Sohag University

Status: Not yet enrolling

Conditions: Minimal Hepatic Encephalopathy

Treatments: Other: Psychometric Hepatic Encephalopathy Score (PHES)

Study type: Observational

Funder types: Other

Identifiers

NCT07272707

Soh-Med--25-11-9MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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):

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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.

Trial design

150 participants in 2 patient groups

Group 1: Cirrhotic Patients (Cases)

Description:

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

Treatment:

Other: Psychometric Hepatic Encephalopathy Score (PHES)

Group 2: Healthy Volunteers (Controls)

Description:

Healthy adults aged 18-70 years with no chronic disease and normal cognitive function undergoing Psychometric hepatic encephalopathy score testing.

Treatment:

Other: Psychometric Hepatic Encephalopathy Score (PHES)