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

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.

NCT Number	NCT07612670
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University Collaborators: The Fifth People's Hospital of Suzhou, Subei People's Hospital of Jiangsu Province, The Third People's Hospital Of Changzhou, The Third People's Hospital of Zhen jiang, Second Affiliated Hospital of Xi'an Jiaotong University
Conditions	Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Liver Cirrhosis
Enrollment	700 participants
Start Date	2026-08-01
Primary Completion	2028-01-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-15