Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test
研究概览
简要总结
Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant Biliary Strictures
Objectives
- To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis
- To assess the sensitivity, specificity and accuracy of Fluorescent in situ Hybridization(FISH) in malignant biliary stricture diagnosis
Study design One academic center, prospective, diagnostic study
Research Methodology Target population: Patients who are diagnosed malignant biliary stricture. Sample population: Patients who are diagnosed malignant biliary stricture in Chulalongkorn Hospital
详细描述
Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant Biliary Strictures
Objectives
- To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis
- To assess the sensitivity, specificity and accuracy of Fluorescent in situ Hybridization(FISH) in malignant biliary stricture diagnosis
Study design One academic center, prospective, diagnostic study
Research Methodology Target population: Patients who are diagnosed malignant biliary stricture. Sample population: Patients who are diagnosed malignant biliary stricture in Chulalongkorn Hospital
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 year-old
- •All patients who are diagnosed malignant biliary stricture by 3 months and undergo ERCP in Chulalongkorn Hospital.
- •All patients have to sign the consent form
排除标准
- •Cannot follow up for 1 year
- •Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
- •History of fluorescein allergy
结局指标
主要结局
Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test
时间窗: up to 1 year
If investigator can detect malignant biliary stricture more than present, the care giver can treat these patients properly. Consequently, the mortality rate of malignant biliary stricture will be decrease.
次要结局
未报告次要终点
研究者
Rapat Pittayanon, MD
King Chulalongkorn Memorial Hospital
King Chulalongkorn Memorial Hospital