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

NCT01863836 | Completed

• 1 other identifier: IUCPQ-20913
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Pulmonary Lesions

Keywords

Radial endobronchial ultrasound; Peripheral lung lesion; Fluoroscopy; Lung cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Lesion localization

  Immediate (during the test)

• Procedure duration

  During the test

• Complications

  Immediately during the test and up to 4 hours after the test

Study Arms (2)

Fluoroscopy

EXPERIMENTAL

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

No fluoroscopy

ACTIVE COMPARATOR

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

Interventions

Fluoroscopy PROCEDURE

Fluoroscopy

Radial EBUS-guided biopsy PROCEDURE

Fluoroscopy; No fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Therapeutic anticoagulation
• Antiplatelet therapy other than aspirin
• Known hemorrhagic diathesis
• Acute respiratory failure
• Pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Antoine Delage, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)