A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 510
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.
详细描述
Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited.
Recently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings.
A novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.
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
- •They have received colonoscopy for screening, surveillance or symptom investigation;
- •They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;
- •They have histologically proven colorectal neoplasia.
- •Written consent obtained
排除标准
- •Poor quality endoscopic images and videos defined as:
- •Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
- •Artifacts due to mucus, air bubbles, stool, or blood.
- •Active gastrointestinal bleeding;
- •Fulminant colitis;
- •Obscured view due to poor bowel preparation;
- •Artificial staining of lesion due to chromoendoscopy.
- •Unable to obtain informed consent
结局指标
主要结局
Diagnostic accuracy
时间窗: During the colonoscopy
area under receiver operating characteristic curves, AUROC in prediction of final histopathology
次要结局
- Sensitivity(During the colonoscopy)
- Diagnostic time(During the colonoscopy)
- Negative predictive value(During the colonoscopy)
- Specificity(During the colonoscopy)
- Positive predictive value(During the colonoscopy)
研究者
Louis Ho Shing Lau
Assitant Professor
Chinese University of Hong Kong