A randomized-controlled trial of endoscopic treatment of acute esophageal variceal hemorrhage: N-butyl-2-cyanoacrylate injection vs. variceal ligation.

This prospective randomized trial compares the efficacy of N-butyl-2-cyanoacrylate injection and variceal ligation in emergency endoscopic treatment of acute esophageal variceal hemorrhage in patients with portal hypertension and chronic liver disease.Between January 2004 to December 2008 43 patients with endoscopy-proven acute esophageal variceal hemorrhage were randomly assigned to one of the two treatment groups: endoscopic injection with N-butyl-2-cyanacrylate (n=22) and endoscopic variceal ligation (n=21). Vital signs, the amount of blood transfusion and infection status were recorded before and after endoscopic treatment. Within two weeks after initial endoscopic treatment, prophylactic variceal ligation was performed until the varices were eradicated.Success in arresting acute bleeding was no different in either group. The re-bleeding rate was higher in the cyanoacrylate group than the ligation group (13.6% us. 4.7%), with no statistical difference (p=0.60692). The mean amount of blood transfused was similar in both groups. Ten (45.5%) patients in the cyanoacrylate group and 7 (33%) in the ligation group died during an observational period of 14.1 +/- 13.9 months and 21.0 +/- 17.2 months, respectively (p=0.3272).The efficacy of endoscopic injection therapy with N-butyl-2-cyanoacrylate to control acute esophageal variceal hemorrhage showed no difference to endoscopic variceal ligation nor did the esophageal variceal re-bleeding rate and mortality rate.