About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.
Trial design
Cohort
Prospective
Treatments tested in this trial
wechat mini-program
Behavioraluse a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
covert hepatic encephalopathy
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.
Secondary outcomes
Sarcopenia
Sarcopenia refers to the loss of muscle mass. The definition is based on the L3-SMI.
decline in quality of life
Evaluated through the SF-36(36-Item Short-Form Health Survey) scale. The SF-36 assesses nine health dimensions. For every dimension (after standard transformation), the minimum possible score is 0 and the maximum possible score is 100. A higher score always indicates a better health outcome or better quality of life.
Other outcomes
DEATH
The patient died.
liver transplantation
TIPS
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
The Fifth People's Hospital of Suzhou
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
The Third People's Hospital Of Changzhou
Collaborator
The Third People's Hospital of Zhen jiang
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: