Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Study Overview
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Brief Summary
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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).

Official Title
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Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy

Conditions
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Solitary Pulmonary Nodule, Lung Cancer

Intervention / Treatment
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* Procedure: Sequential pEBUS - ENB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential pEBUS - ENB<br> | Procedure: Sequential pEBUS - ENB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic yield |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, positive and negative predictive value |  |  | 
| Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield |  |  | 
| Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared |  |  | 
| Complication rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial ultrasound, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Ultrasonography