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

This trial accepts healthy volunteers

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 population

People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • wechat mini-program

    Behavioral

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

Treatment groups

700 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: non-CHE1 intervention
Group B: CHE1 intervention
Group C: liver cirrhosis with sarcopenia0 interventions
Group D: liver cirrhosis without sarcopenia0 interventions
Group E: liver cirrhosis with decline in quality of life0 interventions
Group F: liver cirrhosis without decline in quality of life0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
from the time of enrollment until the end of the 2-year follow-up period

Secondary outcomes

1

Sarcopenia

Sarcopenia refers to the loss of muscle mass. The definition is based on the L3-SMI.

Time frame
From enrollment to the end of treatment at 2 years
2

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.

Time frame
From enrollment to the end of treatment at 2 years

Other outcomes

1

DEATH

The patient died.

Time frame
From enrollment to the end of treatment at 2 years
2

liver transplantation

Time frame
From enrollment to the end of treatment at 2 years
3

TIPS

Time frame
From enrollment to the end of treatment at 2 years

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: