ENB for the Diagnosis of PPNs:a Real World Study

Shanghai Jiao Tong University

Status: Completed

Conditions: Peripheral Pulmonary Nodules

Treatments: Procedure: Electromagnetic navigation bronchoscopy (ENB)

Study type: Observational

Funder types: Other

Identifiers

NCT03716284

2017YFC0112701-2

Details and patient eligibility

About

The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.

Full description

The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

Enrollment: 479 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who are older than 18 year-old.
2. Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion criteria

1. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
2. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.