Phase III Study of the Efficacy of Endoscopic Ultrasound (EUS) Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
研究概览
简要总结
Consecutive patients who meet the eligibility criteria will be enrolled into the study. All patients with gastric varices with no history of gastric variceal bleed (Group C) will undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of first year and at the end of study.
The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90 patients will be enrolled and randomized into group A and Group B after resuscitation and urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to achieve hemostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological or histologic diagnosis of cirrhosis
- •Upper Gastrointestinal endoscopy showing gastric varices
- •Informed consent to participate in the study
排除标准
- •Previous endotherapy (Endoscopic Variceal Ligation/Esophageal Variceal Sclerotherapy/Endoscopic Variceal Obliteration) for gastric variceal haemorrhage
- •Diagnosed case of HepatoPulmonary Syndrome.
- •Non -cirrhotic portal hypertension/Extra hepatic Portal Venous Obstruction
- •transhepatic intrajugular portosystemic shunt, (balloon-occluded retrograde transvenous obliteration), balloon-occluded endoscopic injection sclerotherapy, shunt operation.
- •Hepatic encephalopathy grade III/IV,
- •Cardio respiratory failure
- •Pregnancy
结局指标
主要结局
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
时间窗: 2 years
次要结局
- Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.(2 years)
- Proportion of patients who will achieve complete Gastric variceal obliteration in both groups(2 years)