A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy

NCT07612670 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Observational

Started

2026-10-01

Last updated

2026-10-01

Condition(s) studied

Hepatic EncephalopathyMinimal Hepatic EncephalopathyLiver Cirrhosis

Investigational drug(s) / intervention(s)

wechat mini-program

wechat mini-program: use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly

Study summary

Purpose Hepatic encephalopathy (HE) is a serious complication of liver cirrhosis that can cause memory loss, slow reaction, and even coma. In China, large-scale epidemiological data on HE are lacking, early diagnosis remains difficult, and treatment needs improvement. This study aims to investigate the prevalence of HE in Chinese liver disease patients and to explore better diagnostic methods and treatment strategies.

Design This is a prospective, multicenter cohort study led by Jiangsu Province Hospital, in collaboration with 7 other hospitals in Jiangsu Province. Between April 2026 and December 2029, the study plans to enroll over 700 patients with liver cirrhosis and 120 healthy volunteers.

What participants will do Participants will use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly. They will be followed up at month 1, 3, 6 after enrollment, and then every six months. The research team will collect routine laboratory results, medication records, and quality-of-life data.

Benefits and risks Participants will receive closer health monitoring, which may help detect changes early. The study involves no additional drugs or invasive procedures, so risks are very low. All personal information will be kept strictly confidential and used only for medical research.

Voluntary participation Participation is completely voluntary, and participants can withdraw at any time without affecting their routine medical care.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Accepted

Inclusion Criteria: * For patients with liver cirrhosis and the general healthy population, the diagnosis of liver cirrhosis is made by doctors based on imaging, elastography, biopsy or clinical symptoms. * The patients themselves and their accompanying family members have smart phones, are proficient in using WeChat and mini-programs, and have a stable network environment. * They voluntarily sign the informed consent form, have good compliance, and fully understand this study. Exclusion Criteria: * Age \< 18 years old; * Women planning to get pregnant, already pregnant or during lactation; * Incomplete relevant data information required; * Unable to proficiently use WeChat mini-program or unstable network environment; * Red-green color blindness or other irreparable visual impairments; * Heart, lung, or kidney failure or unstable vital signs; * Unwilling to participate in the study or unable to sign the informed consent form; * Any other situation that may interfere with the study assessment, increase the risk for the subjects, or affect their completion of the study, as judged by the researcher and deemed unsuitable for participating in this study; * Have participated in or are currently participating in other clinical trials within the past 3 months;

Primary outcome measure(s)

covert hepatic encephalopathy — from the time of enrollment until the end of the 2-year follow-up period
Patients classified as level 0-1 according to the West Haven classification. The West Haven classification system for hepatic encephalopathy, formally titled the West Haven Classification for Hepatic Encephalopathy, is a semi-quantitative grading system widely used in clinical practice and research to assess the severity of hepatic encephalopathy in patients with cirrhosis. The evaluation is based on a comprehensive clinical assessment of four domains: level of consciousness, intellectual and behavioural function (including orientation, personality, mood, and attention), neuromuscular function (including asterixis, tendon reflexes, and ataxia), and ability to perform activities of daily living. Using these criteria, hepatic encephalopathy is classified into grades ranging from a minimum of Grade 0 to a maximum of Grade 4.

Trial sites (1)

Facility	City	Region	Status
Jiangsu Province Hospital	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612670 on ClinicalTrials.gov ↗ ← All trials in China