Hepatic Encephalopathy, Liver Cirrhosis, Minimal Hepatic Encephalopathy
Conditions
Brief 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.
Detailed description
Hepatic encephalopathy is a common and serious complication of liver cirrhosis, which greatly affects the quality of life and survival prognosis of patients and imposes a heavy burden on the medical and health system. Among patients with liver cirrhosis, the prevalence of overt hepatic encephalopathy is 10-14%, rising to 16-21% in decompensated liver cirrhosis patients, and reaching 10-50% in those who have undergone transjugular intrahepatic portosystemic shunt (TIPS). The prevalence of minimal hepatic encephalopathy (mHE) ranges from 20% to 80%. Currently, the diagnosis of hepatic encephalopathy still relies on exclusion, and the first-line treatments are lactulose and rifaximin. In summary, there are many patients with hepatic encephalopathy, diagnosis is difficult, and the treatment effect is also limited. Studying the specific conditions of Chinese patients, improving diagnostic methods, and exploring more precise treatment plans are of great significance for improving the quality of life of patients and reducing the medical burden.
Interventions
BEHAVIORALwechat mini-program
use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
Sponsors
The First Affiliated Hospital with Nanjing Medical University
The Fifth People's Hospital of Suzhou
Subei People's Hospital of Jiangsu Province
The Third People's Hospital Of Changzhou
The Third People's Hospital of Zhen jiang
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sarcopenia | From enrollment to the end of treatment at 2 years | Sarcopenia refers to the loss of muscle mass. The definition is based on the L3-SMI. |
| decline in quality of life | From enrollment to the end of treatment at 2 years | 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. |
Countries
China
Contacts
CONTACTChuanlong Zhu
Outcome results
None listed