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

INTRODUCTION

The optimal duration of octreotide infusion for esophageal variceal bleeding remains unclear. We aimed to compare the efficacy of 1-day vs 5-day octreotide infusion combined with endoscopic therapy, with the primary outcome of early (5-day) rebleeding under a noninferiority framework and secondary outcomes of 6-week rebleeding and all-cause mortality.

METHODS

This nationwide, multicenter, noninferiority, open-label, randomized, controlled trial included 220 patients with cirrhosis and acute esophageal variceal bleeding who underwent endoscopic band ligation in 5 tertiary-care and 3 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. Rebleeding, transfusion requirements, and mortality were assessed.

RESULTS

Most participants were men (180/220), and the average age was 56 years. The 5-day rebleeding (1.83% vs 1.80%, P ≥ 0.99), 6-week rebleeding (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-day and 5-day groups. The event-rate difference in early rebleeding was 0.03%, indicating noninferiority (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.

DISCUSSION: After successful endoscopic band ligation, the 1-day regimen of octreotide had a noninferior effect compared with the standard 5-day regimen in the prevention of 5-day rebleeding and exhibited no significant differences in the prevention of 6-week rebleeding and all-cause mortality. Trial registration number: Thai Clinical Trials Registry, TCTR 20221004008.