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Noninvasive Methods for Predicting the Occurrence of Decompensation in Chronic Liver Disease: a Prospective, Observational, Multicenter Study
Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels. Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD). Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD. Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China
Start Date
December 16, 2024
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2029
Last Updated
December 19, 2024
2,334
ESTIMATED participants
Lead Sponsor
Nanfang Hospital, Southern Medical University
NCT06163001
NCT05407272
Data Source & Attribution
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