[Primary prevention of digestive hemorrhage, caused by rupture of esophageal varices, by endoscopic sclerotherapy in patients with liver cirrhosis. Multicenter randomized controlled study]. / Prophylaxie primaire des hémorragies digestives par rupture de varices oesophagiennes par sclérothérapie endoscopique chez le malade atteint de cirrhose. Etude contrôlée randomisée multicentrique.

ABSTRACT

The severity of esophageal variceal bleeding in cirrhotic patients justifies prophylactic therapy. A multicenter controlled study was carried out in Languedoc in 116 cirrhotic patients with esophageal varices and no history of bleeding. Patients were randomly assigned to two groups 60 control patients without therapy; 56 patients treated by endoscopic sclerotherapy (209 sessions). The mean follow-up was 20 +/- 11 months. Esophageal varices disappeared in 35 patients (62.5%) or became smaller in 10 other patients (18%). Varices reappeared in 9 of these 35 patients within 3 months. Minor (fever, dysphagia, stenosis) or major complications (variceal bleeding, bacterial peritonitis) were noted in 26 patients (46%). Esophageal variceal bleeding occurred in 13 of the treated patients and in 10 control patients. Actuarial curves of bleeding and survival were similar for both groups. Twenty controls and 21 treated patients died during the study. In conclusion, prophylactic sclerotherapy of esophageal varices should not be performed in cirrhotic patients, considering lack of efficacy and high rate of side effects.