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

Primary Purpose

Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard FB with fluoroscopy
R-EBUS with ultrathin bronchoscope
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Lesions focused on measuring Peripheral pulmonary lesions, Solitary pulmonary lesions, Multiple pulmonary lesions

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medstar Washington Hospital Center
  • University of Florida
  • Johns Hopkins University
  • Washington University Saint Louis
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard FB with fluoroscopy

R-EBUS with ultrathin bronchoscope

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2014
Last Updated
August 28, 2018
Sponsor
Medical University of South Carolina
Collaborators
Olympus, Johns Hopkins University, Medstar Health Research Institute, Mayo Clinic, Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02146131
Brief Title
Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Olympus, Johns Hopkins University, Medstar Health Research Institute, Mayo Clinic, Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass
Keywords
Peripheral pulmonary lesions, Solitary pulmonary lesions, Multiple pulmonary lesions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard FB with fluoroscopy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
R-EBUS with ultrathin bronchoscope
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard FB with fluoroscopy
Intervention Description
Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
Intervention Type
Device
Intervention Name(s)
R-EBUS with ultrathin bronchoscope
Intervention Description
Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions
Primary Outcome Measure Information:
Title
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nichole T Tanner, MD, M.S.C.R
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Washington University Saint Louis
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-6300
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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