Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02146131|
Recruitment Status : Completed
First Posted : May 23, 2014
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Lesions Pulmonary Nodules Pulmonary Mass||Device: Standard FB with fluoroscopy Device: R-EBUS with ultrathin bronchoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||339 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2014|
|Actual Primary Completion Date :||July 14, 2017|
|Actual Study Completion Date :||July 14, 2017|
Active Comparator: Standard FB with fluoroscopy
Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).
Device: Standard FB with fluoroscopy
Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
Active Comparator: R-EBUS with ultrathin bronchoscope
Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.
Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.
Device: R-EBUS with ultrathin bronchoscope
Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146131
|United States, District of Columbia|
|Medstar Washington Hospital Center|
|Washington, District of Columbia, United States|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States|
|United States, Missouri|
|Washington University Saint Louis|
|Saint Louis, Missouri, United States|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-6300|
|Principal Investigator:||Nichole T Tanner, MD, M.S.C.R||Medical University of South Carolina|