Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.
Bronchoscopy is usually the primary investigation of lesions in the lung. X-ray fluorescence
guides the sampling with brushing, biopsy or trans bronchial needle aspiration (TBNA) if the
lesion not is visible. Ct guided trans-thoracic sampling will be performed if a the sample
is non representative. This will delay the diagnosis, and trans-thoracic sampling has a
higher risk of pneumothorax. The use of a ultrasound miniprobe might increase the diagnostic
yield of bronchoscopy in non visible lesions. The ultrasound probe in a guide sheath is
advanced to the lesion with use of X-ray fluorescence. When the lesion is visualised the
miniprobe is removed and sampling is performed with TBNA, biopsy and brushing through the
guide sheath. If rapid on site cytoevaluation is negative, new TBNA is performed. Previous
trials have shown a diagnostic yield without ultrasound between 40-50% and with ultrasound
between 60-80%. The studies with ultrasound have been performed by "super specialists". This
study will evaluate bronchoscopy with the use of ultrasound miniprobe in clinical practice
without "super specialists". It is a prospective randomised trial.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Diagnostic yield of bronchoscopy
6 months
Yes
Jon A Hardie, MD/PhD
Principal Investigator
Department of Thoracic Medicine, Haukeland University Hospital
Norway:National Committee for Medical and Health Research Ethics
12562
NCT00398970
June 2005
January 2008
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