Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- The incidence of infection after endoscopic treatment
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
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.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
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
- Single (Participant)
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.;
- •Diagnosis of esophageal gastric varices by gastroscopy;
- •Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;
排除标准
- •age <18 y.o. or age > 75 y.o.;
- •Never had the variceal bleeding episode before;
- •Do not have endoscopic injection of tissue adhesive;
- •The cefotiam contraindications: such as allergies, pregnancy etc;
- •combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
- •Known infection before 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;
- •Refuse to participate
研究组 & 干预措施
Prophylactic use of antibiotics group
Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
干预措施: Cefotiam (Drug)
结局指标
主要结局
The incidence of infection after endoscopic treatment
时间窗: 1 week
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment
次要结局
- Rebleeding rate(2 months)
- Mortality rate(2 months)
- All clinical events(2 months)
- Serum endotoxin(before and the first day after endoscopic treatment)
- inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10(before and the first day after endoscopic treatment)
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital