A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL

BackgroundEndoscopic injection of N-butyl-2-cyanoacrylate is the preferred method to treat acute gastric variceal bleeding (GVB). However, its rebleeding rate remains high.ObjectiveTo compare an injection containing 0.5 mL of cyanoacrylate (group A) with an injection containing 1.0 mL of cyanoacrylate (group B).DesignA single-center, randomized, controlled trial.SettingA tertiary referral center.Main Outcome MeasurementOccurrence of rebleeding.PatientsPatients with acute gastric variceal bleeding.ResultsForty-four patients in group A and 47 patients in group B were studied; their clinical characteristics were similar. The treatment stopped active bleeding in approximately 90% of cases in both groups. The rebleeding rate was 29.8% (14/47) in group B compared with 38.6% (17/44) in group A (P = .504; 95% CI, -10.592 to 28.280). On multivariate analysis, concomitant hepatocellular carcinoma, infection, and the size of the gastric varices were independent determinants of rebleeding. More patients in group B than in group A had postinjection fever (>37.5°C) (23/47 vs 12/44, P = .059). Treatment failure, complications, 30-day mortality, and survival did not differ between the 2 groups.ConclusionsDue to the small number of study patients, a double dose of cyanoacrylate injection for GVB cannot be proven to have better hemostatic efficacy than a single dose. Multicenter studies with larger patient numbers are necessary to determine whether a double dose is in fact more efficacious. (This trial was registered at www.clinicaltrials.gov, ID number NCT00735358.)