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临床试验/NCT04216745
NCT04216745Unknown不适用

Microbial Profile of Cholangitis in Patients Undergoing Biliary Intervention

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Evaluation of the microbial profile of cholangitis

研究概览

简要总结

  • To identify the microbial profile in bile and blood for patients with cholangitis.
  • To explore risk factors of cholangitis and outcomes in those patients

详细描述

Under physiological conditions, bile is sterile. Major factors maintaining sterility of bile are a competent sphincter of Oddi and antegrade flow of bile. Other factors are bile salts in the bile duct, Kupffer cells and tight junctions between the hepatocytes that guard against bacteria getting in from the portal circulation. Any break in these physiological barriers leads to infection of the bile. The main source of infection in most cases is the duodenum. Hematogenous spread through the portal venous flow is another route. In addition, bile duct obstruction e.g., stone, is associated with bacterial colonization within the stagnant bile and with increasing biliary pressure, bacteria may translocate into the circulation causing a systemic infection .

In patients without stone disease, previous biliary intervention is associated with high rates of infection. Bacteremia as a complication of biliary intervention tends to occur in patients with obstructed bile flow, especially those who have previously undergone orthotopic liver transplantation (OLT), surgery to the biliary tree, sphincterotomy, or placement of a biliary stent. The risk of systemic infection is high when adequate biliary drainage has not been achieved after intervention, which typically involves endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).

Acute cholangitis is acute inflammation and infection in the bile duct. It is diagnosed in 6-9% of patients with gallstone disease and 1-3% after ERCP. It can progress from a local biliary infection to advanced systemic disease with sepsis and multiple organ dysfunctions with significant mortality rates (10%).

Microbial infection causing acute cholangitis is mainly bacteria and fungi. Despite blood cultures provide an opportunity to detect the causative organism, they remain negative in more than half of the cases with cholangitis. The growth is often mono-microbial organism, predominantly Gram-negative organisms. However, bile cultures often have a poly-microbial growth especially in patients with an indwelling biliary stent where, Gram-negative bacteria, in particular Escherichia coli, are the most common pathogens isolated from infected bile.

The fungal infection of the biliary tract increase in the last years and can lead to biliary obstruction. The most common fungal infection in biliary tract is candidiasis.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD) will be included.

排除标准

  • patients less than 18 years old.

结局指标

主要结局

Evaluation of the microbial profile of cholangitis

时间窗: Up to 24 weeks

to evaluate the microbial profile of cholangitis regarding types of organisms

次要结局

  • Evaluation of short-term mortality(Up to 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Mostafa Salama

Assistant Lecturer

Assiut University

研究点 (1)

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