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

NCT07612670 | Not Yet Recruiting

• 1 other identifier: 2026-SR-358
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy; Minimal Hepatic Encephalopathy; Liver Cirrhosis

Outcome Measures

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.

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

Secondary Outcomes (2)

• Sarcopenia

  From enrollment to the end of treatment at 2 years

• decline in quality of life

  From enrollment to the end of treatment at 2 years

Other Outcomes (3)

• DEATH

  From enrollment to the end of treatment at 2 years

• liver transplantation

  From enrollment to the end of treatment at 2 years

• TIPS

  From enrollment to the end of treatment at 2 years

Study Arms (6)

non-CHE

Patients who did not develop covert hepatic encephalopathy during the follow-up period

Behavioral: wechat mini-program

CHE

Patients who develop covert hepatic encephalopathy during the follow-up period

Behavioral: wechat mini-program

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.

Interventions

wechat mini-program BEHAVIORAL

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

CHE; non-CHE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Fifth People's Hospital of Suzhou: collaborator
• The Third People's Hospital Of Changzhou: collaborator
• The Third People's Hospital of Zhen jiang: collaborator
• Subei People's Hospital of Jiangsu Province: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Related Publications (7)

• Ehrenbauer AF, Egge JFM, Gabriel MM, Tiede A, Dirks M, Witt J, Wedemeyer H, Maasoumy B, Weissenborn K. Comparison of 6 tests for diagnosing minimal hepatic encephalopathy and predicting clinical outcome: A prospective, observational study. Hepatology. 2024 Aug 1;80(2):389-402. doi: 10.1097/HEP.0000000000000770. Epub 2024 Feb 13.

  PMID: 38349709 RESULT

• Li X, Liu S, Guo Y, Zu H, Xiang H, Yang S, Zhang X, Meng F, Bianba Y, Li J, Liu F, Lei C, Lv J, Yang QH, Fu W, Ye W, Chen J, Gao Y, Wu C, Wang N, Zheng Q, Wang F, Yu J, Wang J, Yang X, Wang X, Liu Y, Zhao X, Wu C, Gou W, Bajaj JS, Wang FS, Fu J, Qi X. Detection of minimal hepatic encephalopathy in patients with cirrhosis based on the Stroop-CN model (NCRCID-CHESS 2106): a prospective multicenter study. MedComm (2020). 2024 Jul 15;5(8):e627. doi: 10.1002/mco2.627. eCollection 2024 Aug.

  PMID: 39015557 RESULT

• Wang J, Deng MJ, Shi PM, Peng Y, Wang XH, Tan W, Wang PQ, Chen YX, Yuan ZL, Ning BF, Xie WF, Yin C. Covert hepatic encephalopathy is associated with aggressive disease progression and poor survival in patients with cirrhosis. J Dig Dis. 2023 Dec;24(12):681-690. doi: 10.1111/1751-2980.13246.

  PMID: 38108656 RESULT

• Allampati S, Duarte-Rojo A, Thacker LR, Patidar KR, White MB, Klair JS, John B, Heuman DM, Wade JB, Flud C, O'Shea R, Gavis EA, Unser AB, Bajaj JS. Diagnosis of Minimal Hepatic Encephalopathy Using Stroop EncephalApp: A Multicenter US-Based, Norm-Based Study. Am J Gastroenterol. 2016 Jan;111(1):78-86. doi: 10.1038/ajg.2015.377. Epub 2015 Dec 8.

  PMID: 26644276 RESULT

• Tapper EB, Henderson JB, Parikh ND, Ioannou GN, Lok AS. Incidence of and Risk Factors for Hepatic Encephalopathy in a Population-Based Cohort of Americans With Cirrhosis. Hepatol Commun. 2019 Sep 6;3(11):1510-1519. doi: 10.1002/hep4.1425. eCollection 2019 Nov.

  PMID: 31701074 RESULT

• Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Sep;74(3):1611-1644. doi: 10.1002/hep.32049. No abstract available.

  PMID: 34233031 RESULT

• Bajaj JS, Jakab SS, Jesudian AB, Rahimi RS, Duarte-Rojo A, Chen PH, Wong RJ, Tapper EB, Tandon P. ACG Clinical Guideline: Hepatic Encephalopathy. Am J Gastroenterol. 2026 Mar 1;121(3):588-618. doi: 10.14309/ajg.0000000000003899. Epub 2026 Mar 3.

  PMID: 41773757 RESULT

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chuanlong Zhu

CONTACT

+8617714316539; zhuchuanlong@jsph.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)