Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Rebleeding from GV or death
研究概览
简要总结
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
排除标准
- •Presence of esophageal varix
- •GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
- •Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV
- •Patients already on beta-blocker or nitrates
- •Undetermined origin of bleeding from esophageal varix or gastric varix
- •Hepatic encephalopathy grade III/IV
- •Hepatorenal syndrome
- •Hepatocellular carcinoma
- •Presence of deep jaundice (serum bilirubin > 10 mg/dl)
- •Cerebrovascular accident
- •Cardiorespiratory failure
- •Pregnancy or patients not giving informed consent for endoscopic procedures
研究组 & 干预措施
1. Endoscopic Cyanoacrylate injection
Endoscopic Cyanoacrylate injection in the gastric varix
干预措施: Endoscopic Cyanoacrylate injection (Procedure)
2. Beta-blocker
Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
干预措施: beta-blocker (propranolol) (Drug)
结局指标
主要结局
Rebleeding from GV or death
时间窗: Overall Study
次要结局
- Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.(Overall Study)