Endoscopic ultrasonography-guided cyanoacrylate injection versus endoscopic cyanoacrylate injection for treating isolated gastric varices type 1 bleeding with spontaneous shunts: a randomized controlled trial.

Background: Isolated gastric varices type 1 (IGV1) with spontaneous shunts carry a high risk of bleeding and ectopic embolization following cyanoacrylate injection. Objectives: This study aimed to compare the efficacy and safety of endoscopic ultrasonography-guided cyanoacrylate injection (EUS-CYA) versus direct endoscopic injection of cyanoacrylate (DEI-CYA) in patients with IGV1 and spontaneous shunts. Design: A prospective randomized controlled trial (RCT). Methods: This prospective RCT enrolled patients with cirrhosis complicated by IGV1 and spontaneous portosystemic shunts. Eligible patients were randomly assigned to either the EUS-CYA group or the DEI-CYA group. The primary outcome was the rebleeding rate, while the secondary outcomes included technical success rate, gastric varices occlusion rate, cumulative non-bleeding rate, mortality rate, and incidence of ectopic embolization. Results: A total of 96 patients were randomized to either the EUS-CYA (n = 47) or DEI-CYA (n = 49) group, both achieving 100% technical success. The rebleeding rate was significantly lower in the EUS-CYA group compared to the DEI-CYA group (19.15% vs 42.86%, p = 0.012), particularly for late rebleeding (17.02% vs 36.73%, p = 0.03). Kaplan-Meier analysis showed that the cumulative non-bleeding rates at 6, 12, 18, and 24 months were higher in the EUS-CYA group compared to the DEI-CYA group (p = 0.042). Mortality rates were similar between the groups (12.77% vs 16.33%, p = 0.621). No ectopic embolization occurred in the EUS-CYA group, while one case of pulmonary embolism was observed in the DEI-CYA group. Conclusion: EUS-CYA demonstrates a higher gastric varices occlusion rate and a lower rebleeding rate for IGV1 with spontaneous shunts compared to DEI-CYA. Trial registration: Chinese Clinical Trial Registry, ChiCTR2200058888.