Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions

UMIN ID: UMIN000000569

Registered date:29/12/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pulmonary peripheral small lesions
• Date of first enrollment: 2006/04/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

With navigation by virtual bronchoscopy
Without navigation by virtual bronchoscopy

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)Difference between bronchi by virtual bronchoscopy and actual bronchi 6)Bronchial generation inserted by bronchoscopy 7)Complication 8)Patient suffering by bronchoscopy

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: First Department of Medicine
• Source(s) of Monetary Support: None