Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy
研究概览
简要总结
In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
- •EUS-FNA is achievable.
- •signed informed consent letter
排除标准
- •pregnant female
- •pancreatic cystic lesions
- •anticoagulant/antiplatelet therapy cannot be suspended
- •unable or refuse to provide informed consent
- •coagulopathy (platelet count <50 ×103/uL, international normalized ration >1.5）
- •severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- •with history of mental disease
- •other medical conditions that are not suitable for EUS-FNA
结局指标
主要结局
Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy
时间窗: 10 months
The interpretation results of endoscopists will be compared with that of cytopathologist.
次要结局
- The results of standard specimens-processing, microscope-operating training on endoscopists(3 months)
研究者
Zhaoshen Li
chief of the gastroenterology
Changhai Hospital