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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398970
First Posted: November 14, 2006
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helse Sunnmore, 6026 Ålesund
Information provided by:
Haukeland University Hospital
  Purpose

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.


Condition Intervention
Lung Cancer Device: Endobronchial ultrasound miniprobe

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Diagnostic yield of bronchoscopy [ Time Frame: 6 months ]

Estimated Enrollment: 240
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional flouroscopy guided sampling Device: Endobronchial ultrasound miniprobe
Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.
Experimental: Ultrasound guide sampling Device: Endobronchial ultrasound miniprobe
Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398970


Locations
Norway
Department of Thoracic Medicine
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Helse Sunnmore, 6026 Ålesund
Investigators
Principal Investigator: Jon A Hardie, MD/PhD Department of Thoracic Medicine, Haukeland University Hospital
  More Information

Publications:
Responsible Party: Jon Andrew Hardie, MD/PhD, Haukeland Univiersity Hospital, Bergen, Norway
ClinicalTrials.gov Identifier: NCT00398970     History of Changes
Other Study ID Numbers: 12562
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Haukeland University Hospital:
Endobronchial ultrasonography
Fluoroscopy
Guide sheath
Peripheral pulmonary lesion
Transbronchial biopsy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases