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Article Abstract
Introduction: 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 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 4 patients in the Con-ECI group, of which 1 patient died. By 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 7.7-12.9) and 9.9 (interquartile range 6.3-12.6) months, respectively.
Discussion: Clipping before ECI reduces the risk of ectopic embolism in patients with fundal varices with a portal-systemic shunt, without compromising safety or efficacy.
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