Patients with advanced hepatocellular carcinoma and acute esophageal variceal bleeding have a very poor prognosis. To compare the efficacy and complications of sclerotherapy and banding ligation, patients with acute esophageal variceal bleeding and concomitant hepatocellular carcinoma were randomly allocated to receive either sclerotherapy (endoscopic injection sclerotherapy group, 27 patients) or banding ligation (endoscopic variceal ligation group, 30 patients). All patients received treatment within 24 h of index bleeding. Initial control of bleeding was achieved in 41% of the endoscopic injection sclerotherapy group and 87% of the endoscopic variceal ligation group (p < 0.001). The re-bleeding rates were 73% and 42%, respectively (p < 0.05). The amount of blood transfused during the week after treatment was significantly higher in the endoscopic injection sclerotherapy than in the endoscopic variceal ligation group (3.9 +/- 1.5 vs. 1.5 +/- 0.8 units, respectively) (p < 0.01). Major complications were more often encountered in the endoscopic injection sclerotherapy group (22%) than in the endoscopic variceal ligation group (3%) (p < 0.05). Twenty-three patients in the endoscopic injection sclerotherapy group and 25 patients in the endoscopic variceal ligation group have so far died. The mean survival was 25 +/- 16 days in the endoscopic injection sclerotherapy group and 49 +/- 14 days in the endoscopic variceal ligation group (p < 0.05). Variceal bleeding was the main cause of mortality in the endoscopic injection sclerotherapy group (70%), whereas in the endoscopic variceal ligation group, hepatic failure (48%), rather than variceal bleeding (28%), was the major cause.(ABSTRACT TRUNCATED AT 250 WORDS)