A prospective randomized study comparing the effects of large and small volumes of the sclerosant 5% ethanolamine oleate injected into esophageal varices.

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 less than 0.05) and disappearance of red color signs (RCS) on the variceal surface (95.0% vs 52.6%, p less than 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 less than 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 persistence 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.