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.
RCT Entities:
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.
Authors: Tom D Catron; George B Smallfield; Le Kang; Richard K Sterling; Mohammad S Siddiqui Journal: Dig Dis Sci Date: 2017-07-12 Impact factor: 3.199
Authors: Y Wu; M Chen; M Huang; G Liao; S Tang; H Zheng; Y Li; B Peng; X Zheng; S Pan; J Hou; B Chen Journal: Nan Fang Yi Ke Da Xue Xue Bao Date: 2021-12-20