An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The recurrence rate of cholangitis
研究概览
简要总结
Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.
详细描述
The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.
The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old
- •diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
- •endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission
排除标准
- •pregnant woman
- •the cause of obstruction other than common bile duct stone
- •severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
- •active concomitant infections of other organs
- •history of allergy to cephalosporin group
结局指标
主要结局
The recurrence rate of cholangitis
时间窗: 8 weeks
The number of patients who has recurrence of fever after complete treatment without other sources identified
次要结局
- Mortality rate(4 weeks)
- The rate of adequacy of drainage(24 hours)
- Complication rate(4 weeks)
研究者
Nisa Netinatsunton
Principal Investigator
Prince of Songkla University