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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

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

Qualifiers

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 design

Treatments tested in this trial

  • wechat mini-program

Treatment groups

700 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

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