Pulmonary Lesions, Pulmonary Mass, Pulmonary Nodules
Conditions
Keywords
Peripheral pulmonary lesions, Solitary pulmonary lesions, Multiple pulmonary lesions
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.
Interventions
DEVICEStandard FB with fluoroscopy
Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
DEVICER-EBUS with ultrathin bronchoscope
Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions
Sponsors
Olympus
Johns Hopkins University
Medstar Health Research Institute
Mayo Clinic
Washington University School of Medicine
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions | 109 |
| 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.
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 | 113 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 61 | 56 |
Baseline characteristics
| Characteristic | R-EBUS With Ultrathin Bronchoscope | Total | Standard FB With Fluoroscopy |
|---|---|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 9.9 | 68.9 years STANDARD_DEVIATION 10.6 | 67.6 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 55 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 85 Participants | 161 Participants | 76 Participants |
| Sex: Female, Male Female | 51 Participants | 107 Participants | 56 Participants |
| Sex: Female, Male Male | 62 Participants | 115 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 113 |
| other Total, other adverse events | 6 / 109 | 5 / 113 |
| serious Total, serious adverse events | 0 / 109 | 0 / 113 |
Outcome results
Primary
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
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.
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard FB With Fluoroscopy | Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions | Diagnostic | 51 participants |
| Standard FB With Fluoroscopy | Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions | Non-Diagnostic | 58 participants |
| R-EBUS With Ultrathin Bronchoscope | Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions | Diagnostic | 62 participants |
| R-EBUS With Ultrathin Bronchoscope | Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions | Non-Diagnostic | 51 participants |