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

Abstract

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.