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Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00925210
First received: June 18, 2009
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Solitary Pulmonary Nodule
Lung Cancer
 Procedure: Sequential pEBUS - ENB
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • diagnostic yield [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sensitivity, specificity, positive and negative predictive value [ Designated as safety issue: No ]
  • Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield [ Designated as safety issue: No ]
  • Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared [ Designated as safety issue: No ]
  • Complication rate [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: David R. Stather, University of Calgary
ClinicalTrials.gov Identifier: NCT00925210     History of Changes
Other Study ID Numbers: 22176
Study First Received: June 18, 2009
Last Updated: September 10, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 16, 2013