Clinical trial NCT00925210: Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
Official title: Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solitary Pulmonary Nodule
Lung Cancer
Keywords: Endobronchial ultrasound
Electromagnetic Navigation Bronchoscopy
Bronchoscopy
Ultrasonography
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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

Primary outcomes:
measure: diagnostic yield
Secondary outcomes:
measure: sensitivity, specificity, positive and negative predictive value
measure: Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
measure: Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
measure: Complication rate
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study officials:
References: