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Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

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ClinicalTrials.gov Identifier: NCT00925210
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
University of Calgary

Brief Summary:
Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).

Condition or disease Intervention/treatment Phase
Solitary Pulmonary Nodule Lung Cancer Procedure: Sequential pEBUS - ENB Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sequential pEBUS - ENB Procedure: Sequential pEBUS - ENB

Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected.

If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected.




Primary Outcome Measures :
  1. diagnostic yield

Secondary Outcome Measures :
  1. sensitivity, specificity, positive and negative predictive value
  2. Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
  3. Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
  4. Complication rate


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >16 years
  • Lung nodule (s) identified on CT scan
  • Clinical decision to obtain tissue biopsy of lung lesion
  • CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)
  • Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic

Exclusion Criteria:

  • Lack of informed consent
  • Nodule less than 1 cm or greater than 6 cm long axis
  • Mediastinal adenopathy >2cm short axis on CT chest
  • Evidence of endobronchial abnormality on chest CT
  • Medical contraindication to bronchoscopy
  • Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.
  • Patient with implanted electronic medical device
  • Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy)
  • Confirmed or suspected pregnancy

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): NCT00925210


Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N4N1
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V4G5
Sponsors and Collaborators
University of Calgary

Additional Information:
Responsible Party: David R. Stather, University of Calgary
ClinicalTrials.gov Identifier: NCT00925210     History of Changes
Other Study ID Numbers: 22176
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Keywords provided by University of Calgary:
Endobronchial ultrasound
Electromagnetic Navigation Bronchoscopy
Bronchoscopy
Ultrasonography

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases