Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer

Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer - Comparison of EBUS-TBNA with vs. without ROSE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001334

Enrollment

120

Registered

2008-08-25

Start date

2008-08-01

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

Lung cancer

Interventions

EBUS-TBNA with ROSE EBUS-TBNA without ROSE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients suspected to have lung cancer with enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT 2. 20 years old or more 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with known lung cancer (e.g., mediastinal staging purposes) 2. Endobronchial lesions 3. Patients with severe concomitant medical illness 4. Bleeding tendency 5. Pregnant woman 6. Other clinical difficulties in this study

Design outcomes

Primary

Measure	Time frame
1. Yields for eliminating the need for additional bronchoscopic procedures	—

Secondary

Measure	Time frame
1. Diagnostic yields (EBUS-TBNA, overall bronchoscopy) 2. Accuracy of EBUS-TBNA 3. Number of needle passes 4. Time of procedure (EBUS-TBNA, overall bronchoscopy) 5. Accuracy of ROSE 6. Frequency of adverse effects	—

Countries

Japan

Contacts

Public ContactMasahide Oki

Nagoya Medical Center Department of Respiratory Medicine

masahideo@aol.com052-951-1111

Outcome results

None listed

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