Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.

This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

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Key information

Conditions

Pulmonary Lesions Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pulmonary Mass Pulmonary Nodules Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medstar Washington Hospital Center, Washington D.C., District of Columbia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR
Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy.
Are at least 22 years old,
Lack Bleeding disorders, and
Are able to provide informed consent

Exclusion criteria

Patients with a pure ground-glass opacity identified on chest CT
Patients with endobronchial involvement seen on chest CT.
Patients who refuse to participate,
Are less than 22 years of age,
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
Are unable to provide informed consent
Pregnant

Treatment and study plan

Standard FB with fluoroscopy

Device

Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

R-EBUS with ultrathin bronchoscope

Device

Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

Primary outcomes

Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

Johns Hopkins University
Mayo Clinic
Medstar Health Research Institute
Olympus
Washington University School of Medicine

Registry information

Official study title

Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 23, 2014
Registry last updated: Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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