Randomized trial of N-butyl-2-cyanoacrylate compared with injection of hypertonic saline-epinephrine in the endoscopic treatment of bleeding peptic ulcers

Background and Study Aims: Theoretically, the injection of cyanoacrylate ma y be effective for peptic ulcer bleeding, but randomized clinical trials ar e rare. The aim of this study was to compare the efficacy of N-butyl-2-cyan oacrylate (Histoacryl) and hypertonic saline-epinephrine (HSE) in the endos copic treatment of major peptic ulcer hemorrhage. Patients and Methods: A total of 126 patients with major peptic ulcer hemor rhage and active bleeding or a nonbleeding visible vessel were randomly all ocated to endoscopic injection with HSE (63 patients; group 1) or to inject ion with Histoacryl (63 patients; group 2). The two groups were well matche d for age, sex, initial hemoglobin values, ulcer size and location, and ble eding stigmata. Results: Initial hemostasis was achieved in 58 cases (92.1%) in group 1 and in 60 cases (95.2%) in group 2 (P=0.717). Rebleeding rates were 16 of 58 i n group 1 and seven of 60 in group 2 (P=0.051). There were no significant d ifferences regarding the rates of permanent hemostasis (51 of 63 in group 1 vs. 57 of 63 in group 2, P=0.203), emergency surgery (seven of 58 in group 1 vs, three of 60 in group 2, P=0.200), or hospital mortality due to bleed ing (0 in group 1 and 0 in group 2). With regard to the rebleeding rate, th ere was a significant difference between group 1 and group 2 in the subgrou p with active arterial bleeding (11 of 26 in group 1 and four of 29 in grou p 2, P=0.039) but not in the subgroup with a nonbleeding visible vessel (fi ve of 32 in group 1 and three of 31 in group 2, P=0.708). There were no sta tistically significant differences in hemostatic results between the two tr eatment groups in the subgroups with gastric ulcers or duodenal ulcers. Alt hough no complications followed HSE therapy, arterial embolization with inf arction occurred in two patients in the Histoacryl group, of whom one died. Conclusions: Compared with HSE injection, Histoacryl injection showed no st atistically significant differences in hemostatic results, except for decre asing the rebleeding rate in the patients with active arterial bleeding. Ho wever, the use of Histoacryl to control peptic ulcer bleeding should be res erved as a last resort before surgery, because of possible embolic complica tion.