Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions

UMIN ID: UMIN000001710

Registered date:16/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: peripheral pulmonary lesions
• Date of first enrollment: 2009/02/01
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

With navigation by virtual bronchoscopy
With X-ray fluoroscopy

Outcome(s)

• Primary Outcome: Yield (Diagnostic rate)
• Secondary Outcome: 1)The time to reach the lesion 2)The time of first biopsy 3)The time of X-ray fluoroscopy 4)The time of total examination 5)Agreement between bronchi by virtual bronchoscopy and actual bronchi 6)Bronchial generation inserted by bronchoscopy 7)Bronchial generation observed by bronchoscopy 8)Complication 9)Pain degree subscale

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Visible by bronchoscopy 2.GGO 3.Lesions deemed as benign diseases on chest CT 4.Severe complication 5.Disability of cessation of anticoagulant or antiplatelet more than 2 days 6.Pregnancy

Related Information

• Primary Sponsor: Department of Pulmonary Medicine, Gifu Prefectural General Medical Center
• Source(s) of Monetary Support: None