Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Peripheral Pulmonary Lesion

Treatments: Device: Bronchoscopic Transparenchymal Nodule Access

Study type: Observational

Funder types: Other

Identifiers

NCT04597346

SHCHE202003

Details and patient eligibility

About

The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.

Full description

The study will be conducted at about 10 clinical centers. Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive BTPNA to sample the target lesions. The primary endpoint is the diagnostic yield of BTPNA. The secondary endpoints include the success rate of navigation, the operation time of the bronchoscope and so on.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients older than 18 years old.
2. Newly diagnosed patients whose chest CT shows peripheral pulmonary lesions that have bronchus signs but are difficult to reach through the intrabronchial path, or are adjacent to the airway, or have no bronchus sign, and are suspected of malignancy which need non-surgical biopsies.
3. The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
4. The location of lesions results in the following situations where transthoracic needle aspiration (TTNA) is difficult to obtain a diagnosis or the operation is relatively risky, or have not been diagnosed by TTNA and other non-surgical biopsies in the past.
5. Lesions can be accessed by BTPNA technology in preoperative assessment.
6. Understand the research and sign the informed consent form.

Exclusion criteria

1. Contraindications for bronchoscopy.
2. The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
3. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
4. Routine bronchoscopy showed visible lesions in the lumen.
5. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.

Sponsors of this trial

Lead Sponsor

Shanghai Jiao Tong University

Collaborating Sponsors

Sichuan University

Zhengzhou University

Capital Medical University

Shandong Public Health Clinical Center

Xi 'an International Medical Center Hospital

Emergency General Hospital

Second Affiliated Hospital of Guangzhou Medical University