Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion

Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion - Randomized study of EBUS-TBB-VBN using 3.0-mm bronchoscope vs. 4.0-mm bronchoscope with GS for peripheral pulmonary lesions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003177

Enrollment

300

Registered

2010-02-13

Start date

2010-02-01

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

Benign or malignant pulmonary lesions

Interventions

EBUS-TBB-VBN using 3.0-mm thin bronchoscope EBUS-TBB-VBN using 4.0-mm bronchoscope

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a peripheral pulmonary lesion 30 mm< in size who need to undergo 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. Re-examination due to prior failure in this trial 5. Case with pure ground glass opacity 6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL) 7. Bleeding tendency 8. Pregnant woman 9. Other clinical difficulties in this trial

Design outcomes

Primary

Measure	Time frame
1. Diagnostic yield on histology specimens	—

Secondary

Measure	Time frame
1. Overall diagnostic yield on the combination of culture, cytology and histology specimens 2. Diagnostic yield according to benign or malignant 3. Diagnostic yield according to lesion 20 mm> or 20 mm< in size 4. Diagnostic yield according to location 5. Visibility on EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Level of bronchus reached 8. Level of bronchus imaged by VBN system 9. Direct visibility of lesions with bronchoscope 10. Time of procedure 11. Frequency of adverse effects	—

Measure

Time frame

1. Overall diagnostic yield on the combination of culture, cytology and histology specimens 2. Diagnostic yield according to benign or malignant 3. Diagnostic yield according to lesion 20 mm> or 20 mm< in size 4. Diagnostic yield according to location 5. Visibility on EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Level of bronchus reached 8. Level of bronchus imaged by VBN system 9. Direct visibility of lesions with bronchoscope 10. Time of procedure 11. 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