Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.

This study has been completed.
Sponsor:
Collaborator:
Helse Sunnmore, 6026 Ålesund
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00398970
First received: November 13, 2006
Last updated: February 25, 2008
Last verified: February 2008

November 13, 2006
February 25, 2008
June 2005
January 2008   (final data collection date for primary outcome measure)
Diagnostic yield of bronchoscopy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Diagnostic yield of Bronchoscopy.
Complete list of historical versions of study NCT00398970 on ClinicalTrials.gov Archive Site
Not Provided
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Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.
Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.

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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Lung Cancer
Device: Endobronchial ultrasound miniprobe
Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.
  • Active Comparator: Traditional flouroscopy guided sampling
    Intervention: Device: Endobronchial ultrasound miniprobe
  • Experimental: Ultrasound guide sampling
    Intervention: Device: Endobronchial ultrasound miniprobe

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with lesions suspicious of malignancy in the lung.

Exclusion Criteria:

  • Patients with lesions assumed to be visible by bronchoscopy.
  • Later proven visible lesion by bronchoscopy.
  • Patients not able to be investigated by bronchoscopy.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00398970
12562
Not Provided
Jon Andrew Hardie, MD/PhD, Haukeland Univiersity Hospital, Bergen, Norway
Haukeland University Hospital
Helse Sunnmore, 6026 Ålesund
Principal Investigator: Jon A Hardie, MD/PhD Department of Thoracic Medicine, Haukeland University Hospital
Haukeland University Hospital
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP