N/A
N=339
Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
Pulmonary Lesions · Pulmonary Nodules · Pulmonary Mass
Bottom Line
View on ClinicalTrials.gov: NCT02146131 ↗Enrolled (actual)
339
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions — 51; 62; 58; 51 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard FB with fluoroscopy (Device); R-EBUS with ultrathin bronchoscope (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions |
51; 62; 58; 51 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02146131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.