A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy
14 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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 de estudio
De observación
Inscripción (Estimado)
700
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Chuanlong Zhu
- Número de teléfono: +8617714316539
- Correo electrónico: zhuchuanlong@jsph.org.cn
Ubicaciones de estudio
-
-
Jiangsu
-
Nanjing, Jiangsu, Porcelana
- Jiangsu Province Hospital
-
Contacto:
- Chuanlong Zhu
- Número de teléfono: +8617714316539
- Correo electrónico: zhuchuanlong@jsph.org.cn
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.
Descripción
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;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
|
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
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
covert hepatic encephalopathy
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sarcopenia
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
DEATH
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to the end of treatment at 2 years
|
From enrollment to the end of treatment at 2 years
|
|
|
TIPS
Periodo de tiempo: From enrollment to the end of treatment at 2 years
|
From enrollment to the end of treatment at 2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de enero de 2028
Finalización del estudio (Estimado)
31 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
16 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Enfermedades metabólicas
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Enfermedades Cerebrales Metabólicas
- Insuficiencia hepática
- Insuficiencia hepática
- Fibrosis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Cirrosis hepática
- Encefalopatía hepática
Otros números de identificación del estudio
- 2026-SR-358
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .