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

Pulmonary Nodules Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146131
• Other study ID #: 00029233
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 14, 2017

Study information

• Verified date: August 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Lesions
• Pulmonary Mass
• Pulmonary Nodules

Intervention

Device:
• Standard FB with fluoroscopy
Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Florida	Gainesville	Florida
United States	Washington University Saint Louis	Saint Louis	Missouri
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Medical University of South Carolina	Johns Hopkins University, Mayo Clinic, Olympus, Washington Hospital Center, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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