An observational study in Minimal Hepatic Encephalopathy, sponsored by Sohag University. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Sohag University · Observational
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.
Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Inclusion Criteria (Cirrhotic Patients):
Adequate vision, hearing, and physical ability to perform the PHES tests.
Inclusion Criteria (Healthy Controls):
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Adequate cognition, hearing, vision, and physical ability.
Exclusion Criteria:
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Compensated cirrhotic patients aged 18-70 years undergoing Psychometric hepatic encephalopathy score testing.
Other: Psychometric Hepatic Encephalopathy Score (PHES)
Healthy adults aged 18-70 years with no chronic disease and normal cognitive function undergoing Psychometric hepatic encephalopathy score testing.
Other: Psychometric 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.
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
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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Yes — De-identified participant data will be made available upon reasonable request.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Sohag University