Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 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 assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
详细描述
At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:
- the prophylactic use of antibiotics group
and 2. the non-prophylactic use of antibiotics group
Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.
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
- •Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- •age between 18-75 years old;
- •Diagnosis of esophageal gastric varices by gastroscopy
- •Preparation of endoscopic injection of tissue adhesive
排除标准
- •No esophageal gastric varices bleeding history;
- •Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
- •The cefotiam contraindications: such as allergies, pregnancy etc;
- •Patients with the other malignant tumor except liver cancer;
- •The preoperative diagnosis of infection;
- •The large amount of ascites;
- •The acute bleeding period (< 5 days);
- •Patients refused to participate in the study.
研究组 & 干预措施
the prophylactic use of antibiotics group
Half an hour before 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)
研究者
Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital