RANDOMIZED TRIAL OF ENDOSCOPIC INJECTION SCLEROSIS WITH ETHANOLAMINE OLEATE AND ETHANOL FOR BLEEDING PEPTIC-ULCER

Background: Few studies have been done comparing ethanolamine oleate i njection therapy with other sclerosing agents. Between September 1992 and August 1995, 78 consecutive patients presenting with a high-risk b leeding ulcer were randomized in a trial comparing endoscopic injectio n sclerotherapies with ethanolamine oleate and absolute ethanol. Metho ds: The groups were well matched in terms of sex, age, clinical featur es, endoscopic findings, and non-steroidal anti-inflammatory drug usag e. We recorded in a prospective randomized trial the initial success o f endoscopy, the rebleeding rate, permanent hemostasis, treatment fail ures, the need for surgery, mortality, and factors related to mortalit y. Results: Initial hemostasis was achieved in 90% (38 of 42) of the e thanolamine oleate group and in 97% (35 of 36) of the ethanol group, a nd permanent hemostasis in 88% (37 of 42) and 92% (33 of 36), respecti vely. The rebleeding rate, 7% and 8%; the emergency surgery rate, 10% and 6%; the transfusion requirement, 4.8 +/- 3.3 units and 4.0 +/- 3.0 units; and the 30-day mortality, 12% and 3%, did not differ significa ntly between the ethanolamine oleate and ethanol groups. Mortality was significantly related to shock at admission, duodenal site of the ulc er, ulcer size greater than 2 cm, and blood transfusion of over 5 unit s. Conclusion: Endoscopic injection sclerotherapies using ethanolamine oleate or absolute ethanol are safe and equally effective for bleedin g peptic ulcers.