Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial.

Abstract

Background: Current guidelines lack clarity about the optimal duration of octreotide therapy for patients with esophageal variceal hemorrhage (EVH). To address this lack of evidence, we conducted a randomized clinical trial (RCT) of 24-hr versus 72-hr continuous infusion of octreotide for patients with EVH.

Methods: This multi-center, prospective RCT (NCT03624517), randomized patients with EVH to 24-hr versus 72-hr infusion of octreotide. Patients were required to undergo esophageal variceal band ligation prior to enrollment. The primary endpoint was rebleeding rate at 72 hr. The study was terminated early due to an inability to recruit during and after the COVID-19 epidemic.

Results: For patients randomized to 72-hr (n = 19) of octreotide vs 24-hr (n = 15), there were no differences in the need for transfusion, average pRBC units transfused per patient (3 units vs 2 units), infection (5 % vs 0 %), mechanical ventilation (11 % vs 7 %), or the need for vasopressors (5 % vs 3 %), respectively (none of these differences were statistically significantly different). There were 2 re-bleeding events in the 72-hr group (11 %), and no re-bleeding events in the 24-hr group (p = 0.49). 8/15 of patients receiving 24 hr of octreotide were discharged at or before hospital day 3 while none in the 72-hr group was discharged before day 3 (p < 0.001). There was one death (in the 72-hr group) within 30 days.

Conclusions: A 24-hr infusion is non-inferior to a 72-hr infusion of octreotide for prevention of re-bleeding in patients with EVH. We propose that shortened octreotide duration may help reduce hospital stay and related costs in these patients.