The Novel Special Light for Endotracheal/Bronchial Lesions.

Shanghai Jiao Tong University

Status: Invitation-only

Conditions: Tracheal Disease; Bronchial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07036614

SHCHE202409

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old;
2. Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
3. Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
4. Patient who has good compliance and sign informed consent;
5. 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.

Exclusion criteria

1. Pregnant or lactating women;
2. No endotracheal/bronchial lesions were detected by bronchoscopy;
3. Allergic reaction to narcotic drugs in previous medical history;
4. The investigator believes that the subject is not suitable for bronchoscopy;
5. High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.

Trial design

400 participants in 1 patient group

Patients with endotracheal/bronchial lesions.

Description:

Approximately 400 patients who meet the inclusion and exclusion criteria will be enrolled to develop and validate the the Novel Special Light for the diagnosis of endotracheal/bronchial lesions.