The Application of Novel Special Light in the Diagnosis of Endotracheal/Bronchial Lesions.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.
研究概览
简要总结
This is a single-center study. The purpose of this study is o evaluate the diagnostic value of special light (TXI, NBI, RDI) in endotracheal/bronchial lesions.
详细描述
The latest endoscopic system, EVIS X1 (Olympus Medical Systems, Tokyo, Japan), was developed in 2020, which includes brighter and clearer WLI, third-generation (3G)-NBI, texture and color enhancement imaging (TXI) ,and red dichromatic imaging (RDI) as a new image-enhanced endoscopy (IEE) . texture and color enhancement imaging (TXI) as a new image-enhanced endoscopy (IEE). The TXI is designed to enhance the 3 image elements of WLI (texture, brightness, and color) using Retinex-based enhancements while maintaining image naturalness (WLI appearance) clearly defines subtle tissue differences. RDI enables observation of deeper tissue regions by utilizing light of longer wavelengths; such light has weak light scattering characteristics, thus providing the opposite effect of NBI. The original purpose of RDI was to reduce the risk of bleeding during endoscopic treatment by improving the visibility of thick blood vessels in deeper tissues. Although great efforts have been made in exploring the various clinical efficacies of RDI, no published reports have comprehensively covered both the technological and clinical aspects of RDI. The purpose of this study is o evaluate the diagnostic value of special light (TXI, NBI, RDI) in endotracheal/bronchial lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 old;
- •Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
- •Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
- •Patient who has good compliance and sign informed consent;
- •The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.
排除标准
- •Pregnant or lactating women;
- •No endotracheal/bronchial lesions were detected by bronchoscopy;
- •Allergic reaction to narcotic drugs in previous medical history;
- •The investigator believes that the subject is not suitable for bronchoscopy;
- •High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.
结局指标
主要结局
Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.
时间窗: 1month
Histopathology will be used as the gold standard. To compare the diagnostic value of the special light (TXI, NBI, RDI) and white light (WLI) in differential diagnosis of benign and malignant luminal lesions.
次要结局
- The diagnostic methods and grading criteria of the special light(1 month)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital