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Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions - Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010795
Enrollment
30
Registered
2013-05-23
Start date
2013-05-23
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

Virtual images toward pulmonary peripheral lesions are produced using Directpath. Transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) is performed using a 2.8-mm ultrathin bronch
channel inner diameter, 1.2 mm
Olympus). Subsequently, endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) /transbronchial needle aspiration (TBNA) with VBN is performed using a 4.0-mm bronchoscope (BF-P260F, inner dia
Olympus).

Sponsors

Gifu Prefectural General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. On chest CT images, an abnormal shadow is present in the peripheral area of the lung field, and bronchoscopy is necessary to make a diagnosis or determine treatment principles 2. 20 years of age or older 3. Consent in writing to participate in this study has been obtained from patients themselves

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

MeasureTime frame
Diagnostic yield

Secondary

MeasureTime frame
Directpath The bronchial generation order allowing automatic virtual image production The bronchial generation order for which manual registration is added Bronchoscope Consistency with virtual images The bronchial generation order allowing insertion and the outer diameter of the bronchus on virtual images The distance from the bronchoscope insertion site to the lesion and the number of bronchial divisions The bronchial generation order allowing observation The bronchial generation order allowing observation Diagnostic yield Diagnostic yields according to the method and bronchoscope used Diagnostic yield according to the lesion size Diagnostic yields according to the distance between the lesion and hilum Diagnosis yields according to the lesion visualization rate using ultrasound, whether the lesion is visualized, and the positional relationship between the ultrasound probe and lesion Visibility on EBUS. Diagnostic yield according to location of probe in relation to target lesion Examination time Safety, Complications

Countries

Japan

Contacts

Public ContactAkifumi Tsuzuku

Gifu Prefectural General Medical Center Department of Pulmonary Medicine and Bronchoscopy

a.tsuzuku@gmail.com058-246-1111

Outcome results

None listed

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