The Study of ENB With Ultra-thin Cryobiopsy in the Diagnosis of Peripheral Pulmonary Nodules

Capital Medical University

Status: Invitation-only

Conditions: Diagnosis

Treatments: Procedure: Cryobiopsy; Procedure: Forceps biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07326072

MR-11-25-060861

Details and patient eligibility

About

To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial

Full description

This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 to 90 years;
2. pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy;
3. chest CT showed that the nodule was located in the segmental bronchus and below, and the maximum diameter of the nodule was 8 mm to 30 mm.It was not accessible by conventional bronchoscopy;
4. if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.

Exclusion criteria

1. contraindications to the bronchoscopy procedure;
2. high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma;
3. electromagnetic source implanted in the body;
4. contraindications to anesthesia;
5. pregnant woman;
6. participated in other studies within three months and did not withdraw or finish, affect the observation of this study;
7. inability or unwillingness to provide informed consent or comply with the follow-up schedule.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Cryobiopsy group

Experimental group

Description:

Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy

Treatment:

Procedure: Cryobiopsy

Forceps biopsy group

Active Comparator group

Description:

Electromagnetic Navigation Bronchoscopic with Forceps Biopsy

Treatment:

Procedure: Forceps biopsy