Sclerotherapy plus octreotide versus sclerotherapy alone in the prevention of early rebleeding from esophageal varices: a randomized, double-blind, placebo-controlled, multicenter trial. New Italian Endoscopic Club.

Because of its ability to decrease portal pressure, azygos blood flow, and postprandial splanchnic hyperemia, octreotide administration could be effective in reducing early rebleeding in patients undergoing endoscopic variceal sclerotherapy (EVS). We report the results of a trial comparing EVS + octreotide versus EVS alone. Consecutive patients with cirrhosis and endoscopically proven variceal hemorrhage were considered eligible for the trial if hemodynamically stable for at least 24 hours after bleeding stopped. Patients with advanced liver cancer or having received EVS treatment in the past were not enrolled. After enrollment patients were submitted to EVS (day 1); all patients were randomized to receive octreotide, 100 micrograms three times a day subcutaneously, or an identical placebo, up to day 29; EVS was repeated at days 8, 15, and 29. Fifty-eight patients were randomized to receive either EVS + octreotide (n = 26) or EVS alone (n = 32). The two groups were evenly balanced for sex, age, Child-Pugh class, history of previous bleeding, endoscopic appearance of varices, or treatment received in emergency. Eight of 26 (31%) patients in the EVS + octreotide group rebled, compared with 11 of 32 (34%) in the EVS group. Four of the eight (50%) patients in the former group and 8 of 11 (73%) in the latter, respectively, bled within day 15. There were 10 (38.5%) deaths in the EVS + octreotide group (seven bleeding-related), compared with seven (21.9%) (five bleeding-related) in the EVS group; these differences did not reach statistical significance. Administration of octreotide, 100 micrograms three times a day, subcutaneously, to patients undergoing EVS for prevention of recurrent variceal bleeding does not decrease the incidence of early rebleeding.

RCT Entities:   Population Interventions Outcomes