Randomized Trial of Endoscopic Injection Sclerosis with Ethanolamine Oleate and Ethanol for Bleeding Peptic Ulcer

Background: Few studies have been done comparing ethanolamine oleate injection therapy with other sclerosing agents. Between September 1992 and August 1995, 78 consecutive patients presenting with a high-risk bleeding ulcer were randomized in a trial comparing endoscopic injection sclerotherapies with ethanolamine oleate and absolute ethanol. Methods: The groups were well matched in terms of sex, age, clinical features, endoscopic findings, and non-steroidal anti-inflammatory drug usage. We recorded in a prospective randomized trial the initial success of endoscopy, the rebleeding rate, permanent hemostasis, treatment failures, the need for surgery, mortality, and factors related to mortality. Results: Initial hemostasis was achieved in 90% (38 of 42) of the ethanolamine oleate group and in 97% (35 of 36) of the ethanol group, and permanent hemostasis in 88% (37 of 42) and 92% (33 of 36), respectively. 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 significantly between the ethanolamine oleate and ethanol groups. Mortality was significantly related to shock at admission, duodenal site of the ulcer, ulcer size greater than 2 cm, and blood transfusion of over 5 units. Conclusion: Endoscopic injection sclerotherapies using ethanolamine oleate or absolute ethanol are safe and equally effective for bleeding peptic ulcers.