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Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Sponsor: Chinese University of Hong Kong
Summary
This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria: 1. effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease), 2. liver stiffness measurements under 25 kPa, and 3. absence of varices as confirmed by endoscopy Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being \<5%. Should this criterion be met, the study will extend to predefined analyses of variceal haemorrhage and hepatic decompensation at 3-and 10-year intervals (funded through local resources; the General Research Fund will cover patient recruitment costs for 1 year). Clinical assessments, laboratory tests, liver and spleen stiffness measurements will be performed at baseline, 3 months, 6 months and 12 months to identify potential predictors of variceal recurrence and assess the feasibility of early identification.
Official title: Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
375
Start Date
2025-01-20
Completion Date
2031-12-31
Last Updated
2025-08-22
Healthy Volunteers
Not specified
Locations (8)
Royal Prince Alfred Hospital
Sydney, Australia
Southern Medical University
Guangzhou, China
Ruijing Hospital
Shanghai, China
Prince of Wales Hospital
Hong Kong, Hong Kong
AIG Hospital
Hyderabad, India
Institute of Liver and Biliary Sciences
New Delhi, India
Changi General Hospital
Singapore, Singapore
National University Hospital, Singapore
Singapore, Singapore