Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Rate of complication that related with infection.
研究概览
简要总结
Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality.
Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected.
In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biliary obstructive disease (Benign or Malignant)
- •19 year-old and older than 19 year-old
排除标准
- •Younger than 19 year-old
- •Patients with leukocytosis (WBC ≥ 11,000/mm3)
- •Body temperature ≥ 38 °C within 72 hours before ERCP
- •History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP
- •Pregnancy women
- •Patients with allergy to beta-lactam
研究组 & 干预措施
Treatment
The intervention group
干预措施: Pacetin® (cefoxitin) (Biological)
Comparator
The comparator group
干预措施: Placebo (Biological)
结局指标
主要结局
Rate of complication that related with infection.
时间窗: within 10 days
次要结局
- Rate of post-ERCP cholangitis(within 10 days)
- Grade of post-ERCP infectious complication(within 10 days)