Randomized study of endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: TBB with 3.0-mm ultrathin bronchoscope vs. TBB followed by transbronchial needle aspiration (TBNA) with 4.0-mm bronchoscope

Randomized study of endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: TBB with 3.0-mm ultrathin bronchoscope vs. TBB followed by transbronchial needle aspiration (TBNA) with 4.0-mm bronchoscope - Randomized study of EBUS-TBB-VBN with 3.0-mm bronchoscope vs. EBUS-TBB/TBNA-VBN with 4.0-mm bronchoscope

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010133

Enrollment

360

Registered

2013-02-28

Start date

2013-02-28

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

Benign or malignant pulmonary lesions

Interventions

EBUS-TBB-VBN using 3.0-mm ultrathin bronchoscope EBUS-TBB/TBNA-VBN using 4.0-mm bronchoscope

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with peripheral pulmonary lesion 30 mm<= in size requiring diagnostic bronchoscopy 2. 20 years old or more 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Prior failure in this trial 5. Case with pure ground glass opacity 6. Patients requiring other bronchoscopic procedures (e.g. EBUS-TBNA, BAL) 7. Bleeding tendency 8. Pregnant woman 9. Other presumed difficulties for patients in this trial

Design outcomes

Primary

Measure	Time frame
1. Diagnostic yield	—

Secondary

Measure	Time frame
1. Diagnostic yield on histology specimens 2. Diagnostic yield: benign or malignant 3. Diagnostic yield according to lesion size: 20 mm> or 20 mm< 4. Diagnostic yield according to location 5. Visibility by EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Diagnostic yield according to procedures (TBB, TBNA, washing) 8. Level of bronchus reached 9. Level of bronchus imaged by VBN system 10. Direct visibility of lesions with bronchoscope 11. Time for examination procedure 12. Incidence of adverse effects	—

Measure

Time frame

1. Diagnostic yield on histology specimens 2. Diagnostic yield: benign or malignant 3. Diagnostic yield according to lesion size: 20 mm> or 20 mm< 4. Diagnostic yield according to location 5. Visibility by EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Diagnostic yield according to procedures (TBB, TBNA, washing) 8. Level of bronchus reached 9. Level of bronchus imaged by VBN system 10. Direct visibility of lesions with bronchoscope 11. Time for examination procedure 12. Incidence 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