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Not Yet Recruiting NCT07874204

Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy

Conditions: Liver Cirrhosis, Hepatic Encephalopathy (HE), Minimal Hepatic Encephalopathy

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Summary

The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. The main questions it aims to answer are: Do the total scores of the electronic and paper tests match for the same patient? Do both tests classify patients as having MHE or not in the same way? Researchers will compare the electronic PHES to the paper PHES to see if they produce equivalent results. Participants will: Be assigned by chance to one of two groups. Group A will take the paper test first, then the electronic test the next day. Group B will take the electronic test first, then the paper test the next day. Complete two cognitive tests (one paper-based and one electronic) on two separate days. Provide information about their medical history and complete routine blood tests as part of their standard care.

Eligibility Criteria

Inclusion Criteria: Age between 18 and 75 years. Diagnosed with liver cirrhosis (based on clinical, laboratory, imaging, or liver biopsy). Good cognition, no overt hepatic encephalopathy (OHE, West-Haven grade ≥ II), and able to cooperate with neuropsychological tests. Voluntary signing of informed consent, good compliance, and fully understanding this clinical study. Exclusion Criteria: Uncontrolled neuropsychiatric disorders affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, stroke sequelae, severe depression/anxiety, schizophrenia, etc.). Use of hypnotics, sedatives, or psychotropic drugs within the past month. Severe alcohol dependence or drug abuse history, unable to cooperate with alcohol withdrawal or drug cessation. Use of lactulose at screening.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07874204). StuddyBuddy aggregates publicly available trial information.