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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• covert hepatic encephalopathy [Срок оценки: from the time of enrollment until the end of the 2-year follow-up period]

Вторичные конечные точки (2)

• Sarcopenia [Срок оценки: From enrollment to the end of treatment at 2 years]
• decline in quality of life [Срок оценки: From enrollment to the end of treatment at 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Jiangsu Province Hospital — Нанкин

Публикации

• 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
• 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 s PMID 39015557
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07612670 · 2026-SR-358

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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