内镜下注射胶水与胶水联合BRTO或TIPSS预防胃静脉曲张出血的随机对照试验

Endoscopic Glue Injection vs Glue Plus BRTO or TIPSS for Preventing Gastric Variceal Bleeding: A Randomized Controlled Trial.

作者信息

Biswas Sagnik, Vaishnav Manas, Gamanagatti Shivanand, Swaroop Shekhar, Arora Umang, Aggarwal Arnav, Elhence Anshuman, Gunjan Deepak, Kedia Saurabh, Mahapatra Soumya Jagannath, Mishra Ashwani Kumar

机构信息

Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, New Delhi, India.

Department of Radiodiagnosis and Interventional Radiology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Clin Gastroenterol Hepatol. 2025 May;23(6):954-964.e10. doi: 10.1016/j.cgh.2024.06.023. Epub 2024 Jul 4.

DOI:10.1016/j.cgh.2024.06.023

PMID:38969074

Abstract

BACKGROUND AND AIMS

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.

METHODS

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.

RESULTS

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%) (P = .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%]) (P = .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.

CONCLUSIONS

RI for secondary prophylaxis reduces rebleeding from GV and GV rebleeding-related mortality in patients with GV hemorrhage. (CTRI/2021/02/031396).

摘要

背景与目的

本研究旨在比较内镜下注射氰基丙烯酸酯胶水硬化治疗（EIS-CYA）与EIS-CYA联合放射介入治疗（RI，即经颈静脉肝内门体分流术或球囊闭塞逆行静脉栓塞术）对肝硬化合并贲门静脉曲张急性出血患者二级预防的疗效。主要结局指标为1年时胃静脉曲张（GV）再出血率。

方法

连续纳入因贲门静脉曲张急性出血的肝硬化患者，在接受EIS-CYA初步止血后随机分为两组（每组45例）。在内镜干预（EI）组，定期（1、3、6和12个月）重复EIS-CYA治疗，而在RI组，患者接受经颈静脉肝内门体分流术或球囊闭塞逆行静脉栓塞术，随后进行内镜监测。

结果

EI组1年时GV再出血率高于RI组：11例（24.4%；95%置信区间[CI]，12.9%-39.5%） vs 1例（2.2%；95% CI，0.1%-11.8%）（P = .004；绝对风险差异：22.2%；95% CI，8.4%-36.6%）。EI组GV再出血相关死亡率（8例[17.8%；95% CI，8.0%-32.1%]）显著高于RI组（1例[2.2%；0.1%-11.8%]）（P = .030；绝对风险差异：15.6；95% CI，2.9%-29.2%）；然而，两组全因死亡率无差异（12例[26.7%；95% CI，14.6%-41.9%] vs 7例[15.6%；95% CI，6.5%-29.5%]）。预防1例1年时GV相关再出血所需治疗人数为4.5。