Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.
研究概览
简要总结
Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.
详细描述
This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.
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
- •The presence of a biliary stricture
- •18 years and older
- •Consented to IRB 707-03
排除标准
- •Younger than 18 years of age
- •Unable to collect a bile sample
- •Abnormal postsurgical anatomy preventing collection of a bile sample
结局指标
主要结局
Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.
时间窗: 2 year
Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods
次要结局
- Correlation between bile and serum IgG4 concentrations.(2 years)
研究者
Lewis R. Roberts
Principal Investigator
Mayo Clinic