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Randomized control trial of virtual bronchoscopic navigation system (VBN) guided bronchoscopy in diagnosis of peripheral pulmonary lesion (PPL)

Randomized control trial of virtual bronchoscopic navigation system (VBN) guided bronchoscopy in diagnosis of peripheral pulmonary lesion (PPL)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200807003
Enrollment
80
Registered
2020-08-07
Start date
2020-08-10
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

18&#45

Interventions

One day before the procedure&#44
the bronchoscopist performs image&#45
reconstruction using computer software&#44
LungPoint&#44
to create the 3&#45
D virtual map to reach the target lesion. For the procedure&#44
the bronchoscopist controls the movement of bronchoscope under the guidance of program to reach target lesion. R&#45
EBUS and fluoroscope are applied to confirm target lesion location then the bronchoscopist collects specimens by performing lung biopsy and bronchial brushing. Bronchoalveolar lavage for cytology and
VBN added to routine bronchoscopy,Routine bronchoscopy

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 18-year-old or more patients indicated for bronchoscopy to evaluate pulmonary lesions seen on a CT scan. The target lesion is 3 cm or smaller with CT bronchus sign.

Exclusion criteria

Exclusion criteria: Pregnancy Patients who have endobronchial lesion Patients with contraindication for bronchoscopy: hemodynamic collapse, profound refractory hypoxemia, malignant arrhythmia, bleeding diathesis

Design outcomes

Primary

MeasureTime frame
Time to achieve target lesion Bronchoscope is introduced through the nose until achieving target lesion Stopwatch timer

Secondary

MeasureTime frame
Procedural duration Bronchoscope is introduced through the nose until the procedure is finished Stopwatch timer,Diagnostic yield of VBN 2 weeks post procedure Definite diagnosis on histopathologic finding,Visualization yield of target lesion using R-EBUS Before specimen collection Endobronchial ultrasound imaging,Size of target lesion 1 day before the procedure Software tools,Characteristics of target lesion 1 day before the procedure Software tools,Location of target lesion 1 day before the procedure Software tools

Countries

Thailand

Contacts

Public ContactSupparerk Disayabutr

Faculty of Medicine Siriraj Hospital, Mahidol University

supparearg@gmail.com66851595929

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026