A Prospective Randomized Study Comparing the Effects of Large and Small Volumes of the Sclerosant 5 % Ethanolamine Oleate Injected into Esophageal Varices

Summary

The safety, efficacy and complications of injections of large and small volumes of 5 % ethanolamine oleate (EO) were examined prospectively in the sclerotherapy of esophageal varices in 39 consecutive cirrhotic patients. Twenty patients were randomly allocated to the large-volume group (LVG) injected with up to 30 ml per session, and 19 to the small-volume group (SVG) injected with up to 15 ml per session. The two groups were comparable with regard to age, etiology and severity of liver disease.

Post-injection bleeding occurred in 15.8 % (3/19) after 1-3 sessions in the SVG and in 0 % in the LVG. The LVG showed a significantly higher rate of decrease in variceal size (95.0 % vs 53.2 %. p < 0.06) and disappearance of red color signs (RCS) on the variceal surface (95.0 % vs 52.6 %, p < 0.01) one week after the initial session. The treatment period and number of sessions of endoscopic injection sclerotherapy (EIS) for eradication of varices were significantly (p < 0.01) smaller in LVG than in SVG (LVG: 2.7 ± 0.6 sessions over 4.2 ± 0.7 weeks vs SVG: 5.4 ± 0.9 sessions over 6.0 ± 1.6 weeks). There were no life-threatening complications, and the incidence of minor complications did not differ between the two groups.

The persistance of RCS and the occurrence of post-injection bleeding may imply that esophageal varices are not always completely obliterated despite 1-3 sessions in the SVG.

We conclude that the large volume of EO is superior to the small volume for repeated EIS to eradicate esophageal varices.

Endoscopic injection sclerotherapy - Esophageal varices - 5 % ethanolamine oleate