Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus combination of EBUS-TBNA and transesophageal endoscopic ultrasound with bronchoscope -guided fine needle aspiration (EUS-B-FNA) in the mediastinal staging of non-small cell lung cancer

Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus combination of EBUS-TBNA and transesophageal endoscopic ultrasound with bronchoscope -guided fine needle aspiration (EUS-B-FNA) in the mediastinal staging of non-small cell lung cancer - Randomized study of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009752

Enrollment

240

Registered

2013-01-12

Start date

2013-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

EBUS-TBNA Combination of EBUS-TBNA and EUS-B-FNA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with suspected or proven non-small cell lung cancer who need confirmatory hilar/mediastinal staging for management decision 2. Patients having at least one of the 3 following items: - Hilar/mediastinal lymph nodes (N1 or N2 or N3), 10 mm or greater in short-axis diameter on CT - PET-positive hilar/mediastinal lymph nodes (N1 or N2 or N3) - Central tumor - Primary tumor size >= 30 mm - Primary tumor without FDG uptake 3. 20 years old or more 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with obvious unresectable lung cancer (e.g. distant metastases, mediastinal invasion, bulky N2/N3) 2. Patients for whom lymphadenectomy or surgical hilar/mediastinal staging will be difficult to undergo 3. Patients with recurrent lung cancer 4. Pregnant woman 5. Bleeding tendency 6. Other presumed difficulties for patients in this study

Design outcomes

Primary

Measure	Time frame
1. Sensitivity of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA	—

Secondary

Measure	Time frame
1. Negative predictive value, positive predictive value, specificity and accuracy of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA 2. Time of procedure 3. Frequency of adverse effects	—

Countries

Japan

Contacts

Public ContactMasahide Oki

Nagoya Medical Center Department of Respiratory Medicine

masahideo@gmail.com052-951-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026