One vs Five Days of Octreotide Infusion for Acute Esophageal Variceal Bleeding: A Randomized Controlled Trial

BACKGROUND AND AIMS: The optimal duration of octreotide infusion for esophageal variceal bleeding remains unclear. We aimed to compare the efficacy of 1-day versus 5-day octreotide infusion combined with endoscopic therapy, with the primary outcome of early (5-day) re-bleeding under a non-inferiority framework and secondary outcomes of 6-week re-bleeding and all-cause mortality. METHODS: This nationwide, multicenter, non-inferiority, open-label, randomized, controlled trial included 220 patients with cirrhosis and acute esophageal variceal bleeding who underwent endoscopic band ligation in five tertiary-care and three university-based hospitals across Thailand. They received a 1-day (n=109) or 5-day (n=111) regimen of continuous octreotide infusion after successful endoscopy. Re-bleeding, transfusion requirements, and mortality were assessed. RESULTS: The majority of participants were men (180/220), and the average age was 56 years. The 5-day re-bleeding (1.83% vs. 1.80%, p≥0.99), 6-week re-bleeding (8.26% vs. 10.81%, p=0.52), and 6-week all-cause mortality (5.50% vs. 6.31%, p=0.80) rates were similar between the 1- and 5-day groups. The event-rate difference in early re-bleeding was 0.03%, indicating non-inferiority (95% CI, 3.50-3.56%). Patients in the 1-day group required significantly fewer blood transfusions and had a shorter time to oral diet and shorter hospital stay. CONCLUSIONS: Following successful endoscopic band ligation, the 1-day regimen of octreotide had a non-inferior effect compared to the standard 5-day regimen in the prevention of 5-day re-bleeding and exhibited no significant differences in the prevention of 6-week re-bleeding and all-cause mortality.