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

NCT02146131 | Completed Results

• 1 other identifier: 00029233
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 5

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

Keywords

Peripheral pulmonary lesions; Solitary pulmonary lesions; Multiple pulmonary lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard FB with fluoroscopy

ACTIVE COMPARATOR

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

R-EBUS with ultrathin bronchoscope

ACTIVE COMPARATOR

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

Interventions

Standard FB with fluoroscopy DEVICE

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

Standard FB with fluoroscopy

R-EBUS with ultrathin bronchoscope DEVICE

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

R-EBUS with ultrathin bronchoscope

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Are at least 22 years old,
• Lack Bleeding disorders, and
• Are able to provide informed consent

You may not qualify if:

• Patients with a pure ground-glass opacity identified on chest CT
• Patients with endobronchial involvement seen on chest CT.
• Patients who refuse to participate,
• Are less than 22 years of age,
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
• Are unable to provide informed consent
• Pregnant

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Olympus: collaborator
• Johns Hopkins University: collaborator
• Medstar Health Research Institute: collaborator
• Mayo Clinic: collaborator
• Washington University School of Medicine: collaborator

Study Sites (5)

Medstar Washington Hospital Center

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

Location

University of Florida

Gainesville, Florida, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Washington University Saint Louis

St Louis, Missouri, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-6300, United States

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Kate Taylor
• Organization: Medical University of South Carolina

Talykat@musc.edu

843-792-2297

Study Officials

• Nichole T Tanner, MD, M.S.C.R

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 23, 2014
• Study Start: July 1, 2014
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-08

Locations

US (5)