Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Sensitivity of Light-CT
研究概览
简要总结
In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.
详细描述
Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tissue samples can be obtained via EUS-FNB
- •Signed informed consent letter
排除标准
- •Unable or refuse to provide informed consent
结局指标
主要结局
Sensitivity of Light-CT
时间窗: 1week after procedure
The true positive rate measures the proportion of positives that are correctly identified by Light-CT
次要结局
- Sensitivity of Light-CT(1week after procedure)
- coherence of FFOCT diagnoses by assistant and pathologist(1week after procedure)
- The diagnostic efficacy of Light-CT for different pancreatic diseases(1week after procedure)
研究者
Zhaoshen Li
chief of the Gastroenterology
Changhai Hospital