Artificial Intelligence for Rapid On-site Evaluation (AI-ROSE) for Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Biopsy of Pancreatic Solid Lesions: A Prospective Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Detection the adequacy for diagnosis
研究概览
简要总结
Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.
Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE.
Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have EUS finding of a PSL;
- •Do not have contraindications for FNA/FNB.
排除标准
- •Inability to provide informed consent for the procedure;
- •Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.
结局指标
主要结局
Detection the adequacy for diagnosis
时间窗: During procedure
The primary outcome of the study is to determine how AI compares with ROSE in determining if EUS FNA/FNB sample from PSLs is adequate for diagnosis. This will be interpreted as a percentage in each group. The main study parameter is on-site determination if an EUS FNA/FNB sample is adequate for interpretation and diagnosis
次要结局
- Comparing the accuracy between preliminary diagnosis(During procedure)
研究者
Nirav C Thosani
Associate Professor
The University of Texas Health Science Center, Houston