Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- cholangitis
研究概览
简要总结
Background and aims: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. Their use is intended to decrease or eliminate the incidence of complications following the procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The aim of this prospective comparative study is to compare the occurrence rate of post-procedural complications, such as cholangitis, bacteremia and septicemia between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct obstruction who will undergo therapeutic ERCP procedure.
Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous moxifloxacin and ceftriaxone group, respectively (using simple randomization program). Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes before ERCP procedure, and will be given to a patient for more than 3 days if the patient develops symptoms and signs of cholangitis or septicemia.
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)
排除标准
- •pregnancy
- •hypersensitivity to moxifloxacin and/or ceftriaxone
- •previous antibiotic exposure or theophyllin derivatives medication within 14 days of admission
- •previous history of epilepsy
- •previous history of endocarditis of valvular heart disease
研究组 & 干预措施
Ceftraxone
ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)
干预措施: ceftriaxone (Drug)
Moxifloxacin
Intravenous moxifloxacin (400 mg/day, infused more than 60 min)
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
cholangitis
时间窗: 3 days
To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group
次要结局
- 30 day mortality(30 days)
研究者
Hong Joo Kim
Associate Professor
Kangbuk Samsung Hospital
