SCLEROTHERAPY PLUS OCTREOTIDE VERSUS SCLEROTHERAPY ALONE IN THE PREVENTION OF EARLY REBLEEDING FROM ESOPHAGEAL-VARICES - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL

Because of its ability to decrease portal pressure, azygos blood flow, and postprandial splanchnic hyperemia, octreotide administration coul d be effective in reducing early rebleeding in patients undergoing end oscopic variceal sclerotherapy (EVS). We report the results of a trial comparing EVS + octreotide versus EVS alone. Consecutive patients wit h cirrhosis and endoscopically proven variceal hemorrhage were conside red eligible for the trial if hemodynamically stable for at least 24 h ours after bleeding stopped. Patients with advanced liver cancer or ha ving received EVS treatment in the past were not enrolled. After enrol lment patients were submitted to EVS (day 1); all patients were random ized to receive octreotide, 100 mu g 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, com pared with 11 of 32 (34%) in the EVS group. Four of the eight (50%) pa tients in the former group and 8 of 11 (73%) in the latter, respective ly, bled within day 15. There were 10 (38.5%) deaths in the EVS + octr eotide group (seven bleeding-related), compared with seven (21.9%) (fi ve bleeding-related) in the EVS group; these differences did not reach statistical significance. Administration of octreotide, 100 mu g thre e times a day, subcutaneously, to patients undergoing EVS for preventi on of recurrent variceal bleeding does not decrease the incidence of e arly rebleeding.