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

ConditionMinimal Hepatic Encephalopathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSohag University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Chronic liver disease.

Neuropsychiatric illness.

Use of psychoactive medications.

Illiteracy.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Psychometric Hepatic Encephalopathy Score (PHES)

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group 1: Cirrhotic Patients (Cases)1 intervention
Group B: Group 2: Healthy Volunteers (Controls)1 intervention

Trial outcomes

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.

Time frame
Baseline assessment

Secondary outcomes

1

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
2

Association between PHES total score and liver disease severity

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

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: