Evaluate the Diagnostic Value of Puncture Biopsy for PPL Under the Guidance of Navigation and Radial EBUS: a Real-World Study

Guangzhou Institute of Respiratory Disease

Status

Unknown

Conditions

Lung; Nodes

Treatments

Device: Forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS

Study type

Observational

Funder types

Other

Identifiers

NCT04692038

20201215

Details and patient eligibility

About

The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.

Full description

The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old; 2. Chest CT shows that the peripheral lung noduleswith uncertain diagnosis are adjacent or far from the airway, and/or are difficult to obtain samples by routine biopsy as assessed by investigators; 3. Understand the research and sign the informed consent form.

Exclusion criteria

1. Contraindications for bronchoscopy; 2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery; 3. Bronchoscopy shows visible intra-airway nodules above the 3rd bronchus; 4. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.