Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Electromagnetic Navigation guided transthoracic needle aspiration; Device: CT-guided Transthoracic Needle Aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT03802266

Chest 010

Details and patient eligibility

About

The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.

Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel

Enrollment: 322 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
2. Patients who are older than 18 year-old;
3. Patients voluntarily join the study and give written informed consent for the study.

Exclusion criteria

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Large blood vessels or important structures on the puncture path of peripheral lung tumors；
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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322 participants in 2 patient groups

Electromagnetic Navigation group

Experimental group

Description:

Electromagnetic Navigation Guided Transthoracic Needle Aspiration

Treatment:

Device: Electromagnetic Navigation guided transthoracic needle aspiration

CT group

Active Comparator group

Description:

CT-guided Transthoracic Needle Aspiration

Treatment:

Device: CT-guided Transthoracic Needle Aspiration