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

14 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

700

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
Comportamentale: 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
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
covert hepatic encephalopathy
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sarcopenia
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
DEATH
Lasso di tempo: 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
Lasso di tempo: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
TIPS
Lasso di tempo: From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 gennaio 2028

Completamento dello studio (Stimato)

31 marzo 2028

Date di iscrizione allo studio

Primo inviato

16 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-SR-358

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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