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.