Comparative study of diagnostic performance of advanced imaging techniques versus Standard B-mode for Endoscopic Ultrasound guided tissue acquisition-An Analytical cross-sectional study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Comparison between advanced imaging-techniques versus Standard B-mode for endoscopic ultrasound guided tissue acquisition in terms of Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Diagnostic Accuracy (DA), and Diagnostic yield (DY).
研究概览
简要总结
The current study aims to compare the diagnostic performance ofadvanced imaging-techniques versus Standard B-mode for endoscopic ultrasound guided tissue acquisition****, in a time-framed analytical comparative cross-sectional, single-center study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients undergoing EUS-guided tissue acquisition (using FNB) for solid lesions (gastro-intestinal, pancreatic, biliary system and lymph nodes).
- •Able to comply with the study procedure and provide informed consent.
排除标准
- •Age less than 18 years
- •Pregnancy
- •Presence of active bleed
- •Presence of coagulopathy, as evidenced by INR>1.5 and platelets <50,000
- •Patients on anti-coagulants or anti-platelets (eg- Clopidogrel).
- •Inability to sample because of intervening blood vessels seen during imaging or EUS (No suitable window found)
- •Poor patient tolerance to the procedure
- •Patients not willing to participate in the study.
结局指标
主要结局
Comparison between advanced imaging-techniques versus Standard B-mode for endoscopic ultrasound guided tissue acquisition in terms of Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Diagnostic Accuracy (DA), and Diagnostic yield (DY).
时间窗: Baseline - At the time of EUS- guided tissue sampling | EUS-guided tissue Diagnosis - Day 4 of the procedure (when histopathology report is available) | In case of negative diagnosis of malignancy - 6 months
次要结局
- 1. Find out the elastography pattern of solid lesions undergoing EUS-guided tissue acquisition.(2. Find out the contrast enhancement pattern of solid lesions undergoing EUS-guided tissue acquisition.)
研究者
Dr Nikhil Sonthalia
Institute of Gastrosciences, Apollo Multispecialty Hospital