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

14 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

700

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
Gedragsmatig: 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
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
covert hepatic encephalopathy
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sarcopenia
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DEATH
Tijdsspanne: 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
Tijdsspanne: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
TIPS
Tijdsspanne: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Medewerkers

Second Affiliated Hospital of Xi'an Jiaotong University
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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 januari 2028

Studie voltooiing (Geschat)

31 maart 2028

Studieregistratiedata

Eerst ingediend

16 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-SR-358

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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