Carvedilol Plus Endoscopic Ligation or Not for Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: A Randomized Controlled Trial

What this Trial Is About

This research aims to compare the effectiveness of carvedilol combined with endoscopic variceal ligation (EVL) versus carvedilol alone in preventing the first esophageal variceal bleeding in patients with cirrhosis who do not respond to carvedilol. The study also seeks to learn about the safety of combining carvedilol with EVL and to explore differences in other gastrointestinal bleeding, liver complications, overall survival, adverse events, and tolerability between the two approaches. Participants will be randomly assigned to one of two groups: one group will take carvedilol daily starting at 6.25 mg and increasing to 12.5 mg if tolerated, along with EVL procedures every 3 to 4 weeks until varices are eradicated, followed by regular endoscopic checkups; the other group will take carvedilol alone with the same dosing schedule. The study is open-label and includes regular clinical visits and follow-ups according to protocol. During the study, participants will visit the clinic every 2 to 3 months for checkups and tests. They will keep a diary to record vital signs such as systolic and diastolic blood pressure and heart rate, as well as any symptoms. The main outcome measured is the occurrence of esophageal variceal bleeding over three years. Secondary outcomes include other upper gastrointestinal bleeding, liver decompensation events, overall survival, and adverse events. The study is sponsored by Taipei Veterans General Hospital, Taiwan.

Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders