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

NCT ID: NCT02146131

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-07-14

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.

Conditions

Pulmonary Lesions; Pulmonary Nodules; Pulmonary Mass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard FB with fluoroscopy

Intervention Type: DEVICE

Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

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.

Group Type: ACTIVE_COMPARATOR

R-EBUS with ultrathin bronchoscope

Intervention Type: DEVICE

Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

Interventions

Standard FB with fluoroscopy

Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nichole T Tanner, MD, M.S.C.R

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Washington University Saint Louis

St Louis, Missouri, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00029233

Identifier Type: -

Identifier Source: org_study_id