A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Bleeding from gastric varix or death
研究概览
简要总结
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.
详细描述
Patients are followed up every 3 months or at the time of end point or complications.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
排除标准
- •Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
- •Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding 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 and patients not giving informed consent for endoscopic procedures
研究组 & 干预措施
Endoscopic Cyanoacrylate injection
Endoscopic injection of cyanoacrylate in the gastric varix until obturation
干预措施: Endoscopic cyanoacrylate injection (Procedure)
Beta-blocker (propranolol)
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
Bleeding from gastric varix or death
时间窗: Within 2 years
次要结局
- Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications(Within 2 years)