Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Detection rate of minimal hepatic encephalopathy using PHES
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Chronic liver disease.
- •Neuropsychiatric illness.
- •Use of psychoactive medications.
- •Illiteracy.
结局指标
主要结局
Detection rate of minimal hepatic encephalopathy using PHES
时间窗: Baseline assessment
Proportion of compensated cirrhotic patients classified as having minimal hepatic encephalopathy based on PHES total score and normative regression equations.
次要结局
- Comparison of PHES subtest performance between cirrhotic patients and healthy controls(Baseline)
- Association between PHES total score and liver disease severity(Baseline)
研究者
Sara Sabry Thabit
Sohag , Akhmim, Schools street
Sohag University