An interventional study of Fluoroscopy and Radial EBUS-guided biopsy in Peripheral Pulmonary Lesions, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Laval University · Not applicable, Interventional, and Diagnostic
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).
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Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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 · Procedure: Radial EBUS-guided biopsy
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
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.
Time frame: 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.
Time frame: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test
Lesion localization
Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.
Time frame: Immediate (during the test)
Procedure duration
Total duration of the bronchoscopic test.
Time frame: 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.
Time frame: Immediately during the test and up to 4 hours after the test
Plan to share: No
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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