Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398970
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2006-11-13
Brief Title:
Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bronchoscopy of non visible lesions in the lung have a low diagnostic yield The use of endoscopic ultrasound might increase the diagnostic yield This prospective study randomises between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use of a miniprobe in clinical practice at Haukeland University Hospital
The study hypothesis
The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions
The study hypothesis
The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None