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

NCT ID: NCT01863836

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-04-30

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

Conditions

Peripheral Pulmonary Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluoroscopy

Intervention Type: PROCEDURE

Radial EBUS-guided biopsy

Intervention Type: PROCEDURE

No fluoroscopy

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.

Group Type: ACTIVE_COMPARATOR

Radial EBUS-guided biopsy

Intervention Type: PROCEDURE

Interventions

Fluoroscopy

Intervention Type: PROCEDURE

Radial EBUS-guided biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Antoine Delage

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoine Delage, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

IUCPQ-20913

Identifier Type: -

Identifier Source: org_study_id