Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Blood culture positive incidence
研究概览
简要总结
Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.
详细描述
Objective
To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not.
Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of esophageal achalasia
- •Ready to have the treatment as POEM and no contraindication of POEM
- •Ability to get informed consent
排除标准
- •Patients who had indications for antibiotic prophylaxis as determined by the American Society for Gastrointestinal Endoscopy
- •Patients who had received antibiotics for any reason within the previous 7days
- •Patients who had possible signs of any infection at the time of the procedure
- •Patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.
研究组 & 干预措施
no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
干预措施: no antibiotic prophylaxis (Drug)
second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
干预措施: second-generation cephalosporin (Drug)
结局指标
主要结局
Blood culture positive incidence
时间窗: after 12 hours of POEM
To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
次要结局
- procalcitonin level(after 12 hours of POEM)