Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).

Detailed Description
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See above

Official Title
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Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions

Conditions
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Peripheral Pulmonary Lesions

Intervention / Treatment
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* Procedure: Fluoroscopy
* Procedure: Radial EBUS-guided biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially) Adults over the age of 18 Exclusion Criteria: Therapeutic anticoagulation Antiplatelet therapy other than aspirin Known hemorrhagic diathesis Acute respiratory failure Pregnancy Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoroscopy<br>Patients will undergo bronchoscopy and radial endobronchial ultrasound-guided biopsy of a peripheral lung lesion like patients in the other group. However, single-plane fluoroscopy will be used to help locate the lesion (with the help of a steerable curette) in case of failure to locate the lesion, and it will also be used to guide tissue sampling and ensure appropriate sampling tool function. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. | Procedure: Fluoroscopy<br> <br> Procedure: Radial EBUS-guided biopsy<br> <br> |
| Active Comparator: No fluoroscopy<br>Patients will undergo biopsy of peripheral lung lesions using radial endobronchial ultrasound guidance only, without the use of fluoroscopy. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. | Procedure: Radial EBUS-guided biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement. | Upon production of pathology results, usually within 2 weeks after the test | 
| Sensitivity and specificity | Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution. | Upon completion of ancillary or confirmatory tests, usually within 2 months after the test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion localization | Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound. | Immediate (during the test) | 
| Procedure duration | Total duration of the bronchoscopic test. | During the test | 
| Complications | occurrence of pneumothorax (and its management), bleeding more than 50ml, sustained desaturation below 90%, cardiac dysrhythmias, or any other adverse events occuring during or after the procedure. | Immediately during the test and up to 4 hours after the test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial endobronchial ultrasound, Peripheral lung lesion, Fluoroscopy, Lung cancer