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

Peripheral Pulmonary Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863836
• Other study ID #: IUCPQ-20913
• Status: Completed
• Phase: N/A
• First received: April 19, 2013
• Last updated: September 19, 2016
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Pulmonary Lesions

Intervention

Procedure:
• Fluoroscopy

• Radial EBUS-guided biopsy

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Lesion localization	Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.	Immediate (during the test)	No
Secondary	Procedure duration	Total duration of the bronchoscopic test.	During the test	No
Secondary	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	Yes