NCT05464693Unknown不适用
Clinical-Microbiological Evaluation of the Obstructive Biliary Disease
Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation
研究概览
简要总结
Patients admitted to hospital due to obstructive biliary disease secondary to benign and malign etiologies, undergoing ERCP, will be selected. Bile sample will be taken in ERCP procedure with sterile technique. Its macroscopic appearance will be assessed and biliary culture will be performed.
详细描述
The sample of biliary aspirate will be assessed as follows.
- Its macroscopic appearance will be analyzed: yellow, black, or purulent.
- Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with diagnosis or suspicion of biliary obstruction of any cause
- •Any gender
- •Over 18 years of age
排除标准
- •Patients referred and previously treated at another hospital/clinic
- •Previous ERCP
- •Pregnancy
- •Patient refusal to enter the study
结局指标
主要结局
Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation
时间窗: 1 year
Determine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP.
次要结局
- Bacteria in the obstructed bile duct(1 year)
- Antibiotic susceptibility of isolated bacteria in bile fluid(1 year)
- Bacteria and etiology of obstructive biliary disease(1 year)
研究者
Dr. med. Hector Eloy Tamez Perez
Clinical professor
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (1)
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