A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer

Phase 2

• Conditions: ung cancer

• Registration Number: JPRN-UMIN000001280
• Lead Sponsor: Japan-multinational Trial Organization (JMTO)

Brief Summary

EBUS-TBNA is a standard procedure for pathological evaluation of mediastinal nodal (N2) status of lung cancer, but its feasibility in potentially operable patients with suspicion of minimal N2 remains unestablished. A prospective multicenter study was conducted to assess the feasibility. Clinical stage-IIIA-N2 non-small cell lung cancer (NSCLC) patients with mediastinal nodal enlargement on CT were eligible; patients were ineligible when CT revealed bulky station N2. When EBUS-TBNA revealed negative results, surgical staging procedures were mandatory. Among 20 eligible patients, EBUS-TBNA provided pathological confirmation of N2 (true-positive) in 12 patients. Among 8 patients with negative results with EBUS-TBNA, 4 patients were pathologically diagnosed of N2 disease with surgical staging procedures (false-negative), and 4 were finally diagnosed of non-N2 disease with nodal dissection by thoracotomy (true-negative). As a result, the sensitivity of EBUS-TBNA for N2 evaluation, the primary endpoint, was 75.0%. There documented no Grade 3-5 adverse event.EBUS-TBNA is safe and useful in pathological evaluation of N2 status even in potentially operable NSCLC patients with suspicion of minimal N2 on preoperative CT.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-31
• Study Completion: 2011-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1, Active infection 2, Any other active malignant tumor

Study & Design

• Study Type: Interventional
• Study Design: Not specified