Status:
COMPLETED
Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
Lead Sponsor:
University of Calgary
Conditions:
Solitary Pulmonary Nodule
Lung Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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 bronchosco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00925210
Start Date
June 1 2009
End Date
September 1 2010
Last Update
September 14 2010
Active Locations (2)
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1
Foothills Medical Center
Calgary, Alberta, Canada, T2N4N1
2
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada, G1V4G5