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

BACKGROUND

Endoscopic injection of N-butyl-2-cyanoacrylate is the preferred method to treat acute gastric variceal bleeding (GVB). However, its rebleeding rate remains high.

OBJECTIVE

To compare an injection containing 0.5 mL of cyanoacrylate (group A) with an injection containing 1.0 mL of cyanoacrylate (group B).

DESIGN

A single-center, randomized, controlled trial.

SETTING

A tertiary referral center.

MAIN OUTCOME MEASUREMENT: Occurrence of rebleeding.

PATIENTS: Patients with acute gastric variceal bleeding.

RESULTS

Forty-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 degrees C) (23/47 vs 12/44, P = .059). Treatment failure, complications, 30-day mortality, and survival did not differ between the 2 groups.

CONCLUSIONS

Due 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.