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

Not Applicable

Completed

• Conditions: Peripheral Pulmonary Lesions
• Interventions: Procedure: Radial EBUS-guided biopsy; Procedure: Fluoroscopy

• Registration Number: NCT01863836
• Lead Sponsor: Laval University

Brief Summary

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

See above

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No fluoroscopy	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.
Fluoroscopy	Fluoroscopy	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.
Fluoroscopy	Radial EBUS-guided biopsy	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	Upon production of pathology results, usually within 2 weeks after the test	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.
Sensitivity and specificity	Upon completion of ancillary or confirmatory tests, usually within 2 months after the test	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.

Secondary Outcome Measures

Name	Time	Method
Lesion localization	Immediate (during the test)	Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.
Procedure duration	During the test	Total duration of the bronchoscopic test.
Complications	Immediately during the test and up to 4 hours after the test	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.

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval; 🇨🇦 Québec, Quebec, Canada