A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
liver cirrhosis without decline in quality of life
During the follow-up period, there was not a decline in quality of life.
liver cirrhosis with decline in quality of life
During the follow-up period, there was a decline in quality of life.
CHE
Patients who develop covert hepatic encephalopathy during the follow-up period
干预措施: wechat mini-program (Behavioral)
liver cirrhosis with sarcopenia
Patients who develop sarcopenia during the follow-up period
non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
干预措施: wechat mini-program (Behavioral)
liver cirrhosis without sarcopenia
Patients who did not develop sarcopenia during the follow-up period
研究者
Chuanlong Zhu
professor
The First Affiliated Hospital with Nanjing Medical University