内镜下注射氰基丙烯酸酯前夹闭可减少胃静脉曲张异位栓塞：一项随机对照试验。

Adding Clip Before Endoscopic Cyanoacrylate Injection Decreases Ectopic Embolisms in Gastric Varices: A Randomized Controlled Trial.

作者信息

Wang Guangchuan, Peng Lijun, Li Ping, Mou Haijun, Li Xiaopei, Li Qun, Qi Xingsi, Lu Kemei, Yao Huijing, Wang Wei, Zhao Lianhui, Xia Yifu, Zhang Mingyan, Zhu Junyuan, Ma Jiali, Li Junshan, Li Congxiang, Liu Xiaofeng, Tuo Biguang, Sun Xiubin, García-Pagán Juan Carlos, Zhang Chunqing

机构信息

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.

Department of Gastroenterology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

出版信息

Am J Gastroenterol. 2025 Jul 2. doi: 10.14309/ajg.0000000000003629.

DOI:10.14309/ajg.0000000000003629

PMID:40600964

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.

摘要

引言

氰基丙烯酸酯迁移导致的异位栓塞是一种严重并发症。我们旨在验证以下假设：预先进行夹闭术可降低胃底静脉曲张合并胃肾分流患者在内镜下注射氰基丙烯酸酯（ECI）后发生继发性异位栓塞的风险。

方法

在这项多中心、开放标签、平行分组的随机对照试验中，来自10家三级医院的胃底静脉曲张合并胃肾分流患者被随机分为夹闭辅助ECI组（Clip - ECI，n = 35）和传统ECI组（Con - ECI，n = 35）。主要结局是异位栓塞的发生情况。在首次注射后48小时内进行计算机断层扫描，以筛查氰基丙烯酸酯（用碘油标记）的迁移情况。

结果

两组的技术成功率均为100%。Clip - ECI组氰基丙烯酸酯栓塞的发生率显著低于Con - ECI组（11.4%对42.9%，P = 0.003）。Con - ECI组有4例患者发生有症状的肺栓塞，其中1例死亡。相比之下，Clip - ECI组未观察到有症状的栓塞事件（11.4%对0%，P = 0.114）。未报告与夹闭相关的出血情况。在Clip - ECI组和Con - ECI组中，分别进行了中位随访10.1（四分位间距7.7 - 12.9）个月和9.9（四分位间距6.3 - 12.6）个月，两组之间的总再出血率（14.3%对14.3%）和生存率（97.1%对93.9%）未观察到显著差异。