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

Laval University

Status: Completed

Conditions: Peripheral Pulmonary Lesions

Treatments: Procedure: Radial EBUS-guided biopsy; Procedure: Fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01863836

IUCPQ-20913

Details and patient eligibility

About

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).

Full description

See above

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

133 participants in 2 patient groups

Fluoroscopy

Experimental group

Description:

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.

Treatment:

Procedure: Radial EBUS-guided biopsy

Procedure: Fluoroscopy

No fluoroscopy

Active Comparator group

Description:

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.

Treatment:

Procedure: Radial EBUS-guided biopsy