Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)

Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS) - Comparison of GS vs. Non-GS method during EBUS-TBB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024305

Enrollment

600

Registered

2016-10-06

Start date

2016-10-06

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 with GS EBUS-TBB-VBN without GS

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 older 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Serious concomitant medical illness 2. Central pulmonary lesions 3. Lesion located within the inner third ellipse from the hilum on chest CT 4. Re-examination following prior failure in this trial 5. Case with pure ground glass nodule 6. Patients needing to undergo bronchoscopic procedures for non-target lesion in the same setting 7. Diffuse pulmonary lesions 8. Pregnancy 9. Bleeding tendency 10. Other clinical difficulties in this trial

Design outcomes

Primary

Measure	Time frame
1.Diagnostic yield of histology specimens	—

Secondary

Measure	Time frame
1. Overall diagnostic yield of the combination of culture, cytology, and 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 lesion location relative to the hilum: middle third ellipse or outer third ellipse 5. Diagnostic yield according to lesion location in the bronchopulmonary segment 6. Visibility with EBUS 7. Diagnostic yield according to the probe location relative to the target lesion 8. Diagnostic yield according to the presence of the air bronchus sign 9. Diagnostic yield according to lesion appearance on computed tomography (CT): solid or ground glass nodule 10. Level of bronchus reached 11. Time taken for examination procedure 12. Incidence of adverse effects	—

Measure

Time frame

1. Overall diagnostic yield of the combination of culture, cytology, and 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 lesion location relative to the hilum: middle third ellipse or outer third ellipse 5. Diagnostic yield according to lesion location in the bronchopulmonary segment 6. Visibility with EBUS 7. Diagnostic yield according to the probe location relative to the target lesion 8. Diagnostic yield according to the presence of the air bronchus sign 9. Diagnostic yield according to lesion appearance on computed tomography (CT): solid or ground glass nodule 10. Level of bronchus reached 11. Time taken for examination procedure 12. Incidence of adverse effects

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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