Adding clip before endoscopic cyanoacrylate injection decreases ectopic embolisms in gastric varices: a randomized controlled trial

Background and Aims: Ectopic embolism caused by cyanoacrylate migration is a severe complication. We aimed to test the hypothesis that prior clipping can reduce ectopic embolism secondary to endoscopic cyanoacrylate injection (ECI) in gastric varices with a gastrorenal shunt. Methods: In this multicenter, open-label, parallel, randomized controlled trial, patients with fundal gastric varices and gastrorenal shunts from 10 tertiary hospitals were randomly assigned to clip-assisted ECI (Clip-ECI, n=35) and conventional ECI groups (Con-ECI, n=35). The primary outcome was the occurrence of ectopic embolism. Computed tomography (CT) was performed within 48 hours of the initial injection to screen for cyanoacrylate (marked with lipiodol) migration. Results: The technical success rate was 100% in both groups. The Clip-ECI group had a significantly lower incidence of cyanoacrylate embolism than the Con-ECI group (11.4% vs. 42.9%, p = 0.003). Symptomatic pulmonary embolism occurred in four patients in the Con-ECI group, of which one patient died. In contrast, no symptomatic embolism event was observed in the Clip-ECI group (11.4% vs. 0%, p = 0.114). No clip-related bleeding was reported. No significant differences were observed in the total rebleeding rate (14.3% vs. 14.3%) and survival rate (97.1% vs. 93.9%) between the Clip-ECI and Con-ECI groups during a median follow-up of 10.1 (interquartile range [IQR]: 7.7–12.9) and 9.9 (IQR: 6.3–12.6) months, respectively. Conclusion: Clipping before endoscopic cyanoacrylate injection reduces the risk of ectopic embolism in patients with fundal varices with a portal-systemic shunt, without compromising safety or efficacy.