Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Recruiting · NCT06549673 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Active aetiological factors not addressed in the inclusion criteria (e.g., autoimmune or hereditary liver diseases). However, hepatic steatosis-commonly coexisting with other liver diseases-is not an exclusion criterion unless accompanied by high plasma alanine aminotransferase \>40 U/L or confirmed steatohepatitis.
- Recent hepatic decompensation within the past year (total bilirubin \>50 μmol/L, prothrombin time \>1.3 times the upper normal limit \[unless attributable to use of anti-coagulation\], albumin \<35 g/L, or presence of ascites, variceal haemorrhage or hepatic encephalopathy). Notably, the Baveno VI criteria used LSM \<20-25 kPa and normal platelet count \>150×109/L to rule out varices requiring treatment (19). However, in line with the Baveno VII consensus, which sets an LSM \<25 kPa as the threshold for considering NSBB discontinuation, thrombocytopenia is not an exclusion criterion to allow the cohort to include a wider spectrum of patients.
- Current or history of hepatocellular carcinoma.
- Radiological evidence of portal vein thrombosis.
- History of other malignancies (unless in complete remission for \>5 years).
- History of liver transplantation or liver resection.
- Contraindications to undergoing endoscopy.
- Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension)
Where it is running
8 locations listed.
- Southern Medical University - Guangzhou, China
- Prince of Wales Hospital - Hong Kong, Hong Kong
- AIG Hospital - Hyderabad, India
- Institute of Liver and Biliary Sciences - New Delhi, India
- Ruijing Hospital - Shanghai, China
- Changi General Hospital - Singapore, Singapore
- National University Hospital, Singapore - Singapore, Singapore
- Royal Prince Alfred Hospital - Sydney, Australia