Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Aged 18 years or above

• Evidence of cirrhosis, based on either radiological and/or clinical features

• History of varices, variceal haemorrhage or portal hypertension warranting NSBB

• Removal or suppression of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete hepatitis B virus DNA suppression in chronic hepatitis B, and long-term alcohol abstinence in alcohol-related liver disease)

• LSM \<25 kPa

• Provision of written informed consent

Locations
Other Locations
Australia
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Sydney
China
Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Ruijing Hospital
NOT_YET_RECRUITING
Shanghai
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
India
AIG Hospital
NOT_YET_RECRUITING
Hyderabad
Institute of Liver and Biliary Sciences
NOT_YET_RECRUITING
New Delhi
Singapore
Changi General Hospital
NOT_YET_RECRUITING
Singapore
National University Hospital, Singapore
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
Vincent Wong, MD
wongv@cuhk.edu.hk
85235051299
Backup
Angel Chim, MSc
angelchim@cuhk.edu.hk
85235054205
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 375
Treatments
Patients with cirrhosis
The patient cohort will have the primary aetiological factor of liver disease controlled, low liver stiffness measurement of below 25 kPa by vibration-controlled transient elastography, and the absence of high-risk varices on upper gastrointestinal endoscopy.
Sponsors
Collaborators: Ruijin Hospital North Shanghai Jiao Tong University School of Medicine, Asian Institute of Gastroenterology, India, Southern Medical University, China, Royal Prince Alfred Hospital, Sydney, Australia, Institute of Liver and Biliary Sciences, India, National University Hospital, Singapore, Changi General Hospital
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov