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

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ClinicalTrials.gov Identifier: NCT02146131
Recruitment Status : Completed
First Posted : May 23, 2014
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
Olympus
Johns Hopkins University
Medstar Health Research Institute
Mayo Clinic
Washington University School of Medicine
Information provided by (Responsible Party):
Medical University of South Carolina

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Medical University of South Carolina
Olympus
Johns Hopkins University
Medstar Health Research Institute
Mayo Clinic
Washington University School of Medicine
Investigators
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Principal Investigator: Nichole T Tanner, MD, M.S.C.R Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Informed Consent Form  [PDF] November 9, 2016

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02146131    
Other Study ID Numbers: 00029233
First Posted: May 23, 2014    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018
Keywords provided by Medical University of South Carolina:
Peripheral pulmonary lesions
Solitary pulmonary lesions
Multiple pulmonary lesions
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases