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

Laval University133 enrolled

Overview

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).

See above

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

133

Conditions

Peripheral Pulmonary Lesions

Interventions

FluoroscopyPROCEDURE

Radial EBUS-guided biopsyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval

Québec, Quebec, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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