Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

University of Calgary

Status and phase

Completed

Phase 2

Conditions

Solitary Pulmonary Nodule

Lung Cancer

Treatments

Procedure: Sequential pEBUS - ENB

Study type

Interventional

Funder types

Other

Identifiers

NCT00925210

22176

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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