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Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.


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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Diagnostic yield of bronchoscopy

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jon A Hardie, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Thoracic Medicine, Haukeland University Hospital

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

12562

NCT ID:

NCT00398970

Start Date:

June 2005

Completion Date:

January 2008

Related Keywords:

  • Lung Cancer
  • Endobronchial ultrasonography
  • Fluoroscopy
  • Guide sheath
  • Peripheral pulmonary lesion
  • Transbronchial biopsy
  • Lung Neoplasms

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