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

May 24, 2026 updated by: Chuanlong Zhu, The First Affiliated Hospital with Nanjing Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
Behavioral: wechat mini-program
use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
CHE
Patients who develop covert hepatic encephalopathy during the follow-up period
Behavioral: wechat mini-program
use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
liver cirrhosis with sarcopenia
Patients who develop sarcopenia during the follow-up period
liver cirrhosis without sarcopenia
Patients who did not develop sarcopenia during the follow-up period
liver cirrhosis with decline in quality of life
During the follow-up period, there was a decline in quality of life.
liver cirrhosis without decline in quality of life
During the follow-up period, there was not a decline in quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
covert hepatic encephalopathy
Time Frame: 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.
from the time of enrollment until the end of the 2-year follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia
Time Frame: 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.
From enrollment to the end of treatment at 2 years
decline in quality of life
Time Frame: 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.
From enrollment to the end of treatment at 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEATH
Time Frame: From enrollment to the end of treatment at 2 years
The patient died.
From enrollment to the end of treatment at 2 years
liver transplantation
Time Frame: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
TIPS
Time Frame: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Subei People's Hospital of Jiangsu Province
The Fifth People's Hospital of Suzhou
The Third People's Hospital Of Changzhou
The Third People's Hospital of Zhen jiang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-SR-358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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