Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 in the Bile Duct Cancer Cell; Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- The usefulness of new staining method
研究概览
简要总结
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.
详细描述
Hypothesis
The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.
Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
- •Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
- •Patients who underwent surgical treatment with biliary cancer
- •Patients with bile duct stenosis
排除标准
- •Minors under the age of 19, vulnerable subjects such as illiteracy
- •Necrotic specimens
- •Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- •Samples classified as neoplastic (benign or other)
- •Patient with cholangitis in the bile duct
结局指标
主要结局
The usefulness of new staining method
时间窗: 1 year
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.
次要结局
未报告次要终点
研究者
Sung III Jang
Assistant professor, MD, PhD
Gangnam Severance Hospital