Not Yet RecruitingNot Applicable

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

China700 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

covert hepatic encephalopathy

Timeframe: from the time of enrollment until the end of the 2-year follow-up period

Trial details

NCT IDNCT07612670

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01-31

Contact for this trial

Chuanlong Zhu

+8617714316539 zhuchuanlong@jsph.org.cn

View on ClinicalTrials.gov More Hepatic Encephalopathy trials