A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy
14. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Antatt)
700
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chuanlong Zhu
- Telefonnummer: +8617714316539
- E-post: zhuchuanlong@jsph.org.cn
Studiesteder
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Jiangsu
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Nanjing, Jiangsu, Kina
- Jiangsu Province Hospital
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Ta kontakt med:
- Chuanlong Zhu
- Telefonnummer: +8617714316539
- E-post: zhuchuanlong@jsph.org.cn
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.
Beskrivelse
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;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
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use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
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CHE
Patients who develop covert hepatic encephalopathy during the follow-up period
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use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
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liver cirrhosis with sarcopenia
Patients who develop sarcopenia during the follow-up period
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liver cirrhosis without sarcopenia
Patients who did not develop sarcopenia during the follow-up period
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liver cirrhosis with decline in quality of life
During the follow-up period, there was a decline in quality of life.
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liver cirrhosis without decline in quality of life
During the follow-up period, there was not a decline in quality of life.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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covert hepatic encephalopathy
Tidsramme: from the time of enrollment until the end of the 2-year follow-up period
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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.
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from the time of enrollment until the end of the 2-year follow-up period
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sarcopenia
Tidsramme: From enrollment to the end of treatment at 2 years
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Sarcopenia refers to the loss of muscle mass.
The definition is based on the L3-SMI.
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From enrollment to the end of treatment at 2 years
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decline in quality of life
Tidsramme: From enrollment to the end of treatment at 2 years
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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.
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From enrollment to the end of treatment at 2 years
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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DEATH
Tidsramme: From enrollment to the end of treatment at 2 years
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The patient died.
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From enrollment to the end of treatment at 2 years
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liver transplantation
Tidsramme: From enrollment to the end of treatment at 2 years
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From enrollment to the end of treatment at 2 years
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TIPS
Tidsramme: From enrollment to the end of treatment at 2 years
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From enrollment to the end of treatment at 2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
31. januar 2028
Studiet fullført (Antatt)
31. mars 2028
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
24. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Patologiske prosesser
- Metabolske sykdommer
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Hjernesykdommer, metabolske
- Leversvikt
- Leverinsuffisiens
- Fibrose
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Levercirrhose
- Hepatisk encefalopati
Andre studie-ID-numre
- 2026-SR-358
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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