Prophylactic sclerotherapy in nonalcoholic liver cirrhosis: preliminary results of a prospective controlled randomized trial.

Between June, 1984 and December, 1985, a total of 41 patients were enrolled in a prospective controlled randomized trial comparing prophylactic sclerotherapy and medical treatment for the prevention of the first esophageal variceal bleeding. All patients had nonalcoholic liver cirrhosis, fourth degree varices, and no past history of gastrointestinal bleeding. The patients were randomly assigned to the control group (20 patients) or to the sclerotherapy group (21 patients); most of the patients belonged to Child's classes A and B. After a mean follow-up of 16.8 months, there were 3 variceal bleeding episodes and a 10% mortality rate in the control group whereas neither hemorrhage nor death was observed in the sclerotherapy group. In the latter group, severe complications occurred in 9.5% of the patients; the rate of recurrence after eradication of esophageal varices was 40%. Although there were no statistically significant results, the favorable trend toward a lower bleeding risk and better survival observed in the treated patients suggests that a longer trial in a larger population of cirrhotic patients with a longer follow-up should be considered.

RCT Entities:   Population Interventions Outcomes