The study sought to compare the efficacy of endoscopic injection sclerotherapy with cyanoacrylate glue (EIS-CYA) vs EIS-CYA plus a radiologic intervention (RI) (either transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration) for secondary prophylaxis in patients with liver cirrhosis who presented with acute variceal bleeding from cardiofundal varices. Primary outcome measure was gastric varix (GV) rebleed rates at 1 year. Consecutive cirrhosis patients with acute variceal bleeding from cardiofundal varices were randomized into 2 arms (45 in each) after primary hemostasis by EIS-CYA. In the endoscopic intervention (EI) arm, EIS-CYA was repeated at regular intervals (1, 3, 6, and 12 months), while in the RI arm, patients underwent transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration followed by endoscopic surveillance. GV rebleed rates at 1 year were higher in the EI arm compared with the RI arm: 11 (24.4%; 95% confidence interval [CI], 12.9%–39.5%) vs 1 (2.2%; 95% CI, 0.1%–11.8%) ( .004; absolute risk difference: 22.2%; 95% CI, 8.4%–36.6%). GV rebleed–related mortality in the EI arm (8 [17.8%; 95% CI, 8.0%–32.1%]) was significantly higher than in the RI arm (1 [2.2%; 0.1%–11.8%]) ( .030; absolute risk difference: 15.6; 95% CI, 2.9%–29.2%); however, there was no difference in all-cause mortality between the 2 groups (12 [26.7%; 95% CI, 14.6%–41.9%] vs 7 [15.6%; 95% CI, 6.5%–29.5%]). The number needed to treat to prevent 1 GV-related rebleed at 1 year was 4.5. RI for secondary prophylaxis reduces rebleeding from GV and GV rebleeding–related mortality in patients with GV hemorrhage. (CTRI/2021/02/031396)

中文翻译：

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内窥镜注射胶与胶加 BRTO 或 TIPSS 预防胃静脉曲张出血的比较：随机对照试验


该研究旨在比较氰基丙烯酸酯胶内镜注射硬化疗法 (EIS-CYA) 与 EIS-CYA 加放射干预 (RI)（经颈静脉肝内门体分流术或球囊闭塞逆行经静脉闭塞术）对以下患者进行二级预防的疗效：肝硬化患者因心底静脉曲张而出现急性静脉曲张出血。主要结局指标是 1 年时胃静脉曲张 (GV) 再出血率。连续性心底静脉曲张急性静脉曲张出血的肝硬化患者在 EIS-CYA 初次止血后被随机分为 2 组（每组 45 例）。在内镜干预 (EI) 组中，定期（1、3、6 和 12 个月）重复进行 EIS-CYA，而在 RI 组中，患者接受经颈静脉肝内门体分流术或球囊闭塞逆行经静脉闭塞术，然后进行内窥镜监视。与 RI 组相比，EI 组 1 年 GV 再出血率较高：11（24.4%；95% 置信区间 [CI]，12.9%–39.5%） vs 1（2.2%；95% CI，0.1%– 11.8%) (.004；绝对风险差异：22.2%；95% CI，8.4%–36.6%)。 EI 组中 GV 再出血相关死亡率 (8 [17.8%; 95% CI, 8.0%–32.1%]) 显着高于 RI 组 (1 [2.2%; 0.1%–11.8%]) ( .030 ；绝对风险差异：15.6；95% CI，2.9%–29.2%）；然而，两组之间的全因死亡率没有差异（12 例 [26.7%；95% CI，14.6%–41.9%] vs 7 例​​ [15.6%；95% CI，6.5%–29.5%]）。 1 年时预防 1 次 GV 相关再出血所需治疗的人数为 4.5 人。 RI 用于二级预防可减少 GV 出血患者的 GV 再出血和 GV 再出血相关死亡率。 (CTRI/2021/02/031396)