Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- All clinical events
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
详细描述
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 y.o. ≤age≤75 y.o.;
- •Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection).
排除标准
- •age <18 y.o. or age > 75 y.o.;
- •Never had the variceal bleeding episode before;
- •Do not have endoscopic treatment;
- •combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
- •Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
- •Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
- •Acute variceal bleeding within 5 days.
- •Use of other antibiotics in the past 2 weeks;
- •Refuse to participate
研究组 & 干预措施
Rifaximin Group
Rifaximin 400 mg bid for 2 month,
干预措施: Rifaximin (Drug)
结局指标
主要结局
All clinical events
时间窗: 8 weeks
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.
次要结局
- coagulation function(8 weeks, and 6 months)
- inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta(8 weeks, and 6 months)
- All clinical events(6 months)
- changes of intestinal flora(8 weeks, and 6 months)
- Serum endotoxin,(8 weeks, and 6 months)
- Glucose breath hydrogen test(8 weeks, and 6 months)
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital