Status:
RECRUITING
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Southern Medical University, China
Ruijin Hospital North Shanghai Jiao Tong University School of Medicine
Conditions:
Portal Hypertension
Cirrhosis
Eligibility:
All Genders
18+ years
Brief 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., ...
Detailed Description
1.1 Significance of cirrhosis and portal hypertension Liver cirrhosis is the common final pathway of various chronic liver diseases. Globally, mortality due to cirrhosis have risen from 899 000 in 19...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06549673
Start Date
January 20 2025
End Date
December 31 2031
Last Update
August 22 2025
Active Locations (8)
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1
Royal Prince Alfred Hospital
Sydney, Australia
2
Southern Medical University
Guangzhou, China
3
Ruijing Hospital
Shanghai, China
4
Prince of Wales Hospital
Hong Kong, Hong Kong