"To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation: A Non-inferiority Trail".
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation.
研究概览
简要总结
Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors
排除标准
- •Patients on anti-platelet agents(including aspirin).
- •Patients with deranged coagulation parameters, defined by platelet counts <75,000/mm3 and/or INR >1.8
结局指标
主要结局
Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation.
时间窗: 0 day
次要结局
- Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with size < 2 cm or > 2 cm(0 day)
- Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with respect to site of tumor (pancreas biliary tract or gall bladder).(0 day)