The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis.
The main questions it aims to answer are:
Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
Participants will:
Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.
None
Age under 18 or over 90 years.
History of esophageal variceal bleeding.
Previous treatment for esophageal varices, including endoscopic variceal ligation, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, or surgery.
Contraindications to non-selective beta-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes mellitus, or severe peripheral artery disease.
Parallel
Carvedilol plus endoscopic variceal ligation
Other interventionTake carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol.
Carvedilol alone
DrugTake carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
Esophageal variceal bleeding
The cumulative incidence of esophageal variceal bleeding
Other upper gastrointestinal bleeding
The cumulative incidence of other upper gastrointestinal bleeding
First/further nonbleeding liver decompensation
Events that defined first/further nonbleeding liver decompensation were based on the Baveno VII consensus.
Overall survival
Adverse events
Primary and secondary outcomes categorized by Child-Pugh class in the subgroup analysis
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