目的:尽管孤立性胃静脉曲张1型(IGV1)出血的发生率很低,这种情况非常危险,并且死亡率很高,使其治疗具有挑战性。我们的目的是比较内镜下夹闭联合氰基丙烯酸酯注射液(EC-CYA)与经颈静脉肝内门体分流术(TIPS)治疗IGV1。
方法:在单中心,随机对照试验,IGV1出血患者被随机分为EC-CYA组和TIPS组.主要终点是胃底静脉曲张再出血率和技术成功率。次要终点包括累积非出血率,死亡率,和并发症。
结果:选择了2019年1月至2023年4月的156例患者,并随机分配到EC-CYA组(n=76)和TIPS组(n=80)。两组的技术成功率均为100%。再出血率EC-CYA组为14.5%,TIPS组为8.8%,差异无统计学意义(P=0.263)。Kaplan-Meier分析显示,两组在6、12、24和36个月的累积无出血率无统计学意义(P=0.344)。同样,两组12,24和36个月的累积生存率无统计学意义(P=0.916).各组其他原因出血率分别为13.2%和6.3%,差异无统计学意义(P=0.144)。两组均未发现异位栓塞。TIPS组肝性脑病(HE)发生率高于EC-CYA组(P=0.001)。
结论:两组均能有效控制IGV1出血。值得注意的是,EC-CYA未导致异位栓塞,HE的发生率低于TIPS。
OBJECTIVE: Although the incidence of isolated gastric varices type 1 (IGV1) bleeding is low, the condition is highly dangerous and associated with high mortality, making its treatment challenging. We aimed to compare the safety and efficacy of endoscopic clipping combined with cyanoacrylate injection (EC-CYA) vs. transjugular intrahepatic portosystemic shunt (
TIPS) in treating IGV1.
METHODS: In a single-center, randomized controlled trial, patients with IGV1 bleeding were randomly assigned to the EC-CYA group or
TIPS group. The primary end-points were gastric variceal rebleeding rates and technical success. Secondary end-points included cumulative nonbleeding rates, mortality, and complications.
RESULTS: A total of 156 patients between January 2019 and April 2023 were selected and randomly assigned to the EC-CYA group (n = 76) and TIPS group (n = 80). The technical success rate was 100% for both groups. The rebleeding rates were 14.5% in the EC-CYA group and 8.8% in the
TIPS group, showing no significant difference (P = 0.263). Kaplan-Meier analysis revealed that the cumulative nonbleeding rates at 6, 12, 24, and 36 months for the two groups lacked statistical significance (P = 0.344). Similarly, cumulative survival rates at 12, 24, and 36 months for the two groups were not statistically significant (P = 0.916). The bleeding rates from other causes were 13.2% and 6.3% for the respective groups, showing no significant difference (P = 0.144). No instances of ectopic embolism were observed in either group. The incidence of hepatic encephalopathy (HE) in the
TIPS group was statistically higher than that in the EC-CYA group (P = 0.001).
CONCLUSIONS: Both groups are effective in controlling IGV1 bleeding. Notably, EC-CYA did not result in ectopic embolism, and the incidence of HE was lower than that observed with
TIPS.