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

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: Electromagnetic Navigation guided transthoracic needle aspiration; Device: CT-guided Transthoracic Needle Aspiration

• Registration Number: NCT03802266
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-14
• Last Update Posted: 2019-01-14
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromagnetic Navigation group	Electromagnetic Navigation guided transthoracic needle aspiration	Electromagnetic Navigation Guided Transthoracic Needle Aspiration
CT group	CT-guided Transthoracic Needle Aspiration	CT-guided Transthoracic Needle Aspiration

Primary Outcome Measures

Name	Time	Method
Diagnostic rate	18 months

Secondary Outcome Measures

Name	Time	Method
Operating time	18 months
Adverse events	18 months

Trial Locations

Locations (1)

Shanghai Chest hospital; 🇨🇳 Shanghai, Shanghai, China