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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Lesions; Pulmonary Nodules; Pulmonary Mass
• Intervention / Treatment: Device: Standard FB with fluoroscopy; Device: R-EBUS with ultrathin bronchoscope

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States
      • MedStar Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States
      • University of Florida
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins University
  • Missouri
    • Saint Louis, Missouri, United States
      • Washington University Saint Louis
  • South Carolina
    • Charleston, South Carolina, United States, 29425-6300
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Johns Hopkins University; Mayo Clinic; Washington University School of Medicine; Medstar Health Research Institute; Olympus
• Investigators: Principal Investigator: Nichole T Tanner, MD, M.S.C.R, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Peripheral pulmonary lesions; Solitary pulmonary lesions; Multiple pulmonary lesions
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 00029233