Clinical trial NCT02146131: Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Lesions
Pulmonary Nodules
Pulmonary Mass
Keywords: Peripheral pulmonary lesions
Solitary pulmonary lesions
Multiple pulmonary lesions
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Olympus
name: Johns Hopkins University
name: Medstar Health Research Institute
name: Mayo Clinic
name: Washington University School of Medicine
First posted: 2014-05-23
Enrollment: 339
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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.
3. Are at least 22 years old,
4. Lack Bleeding disorders, and
5. Are able to provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Saint Louis
country: United States
facility: Washington University Saint Louis
state: Missouri
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Nichole T Tanner, MD, M.S.C.R
role: PRINCIPAL_INVESTIGATOR
References: