Trial Outcomes & Findings for Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 ) (NCT NCT02146131)

Last Updated: 2018-09-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

339 participants

Primary outcome timeframe

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

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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 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. 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
Overall Study STARTED	170	169
Overall Study COMPLETED	109	113
Overall Study NOT COMPLETED	61	56

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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 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. 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
Overall Study Physician Decision	61	56

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard FB With Fluoroscopy n=109 Participants 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). 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 n=113 Participants 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. 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	Total n=222 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 11.2 • n=5 Participants	70.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	68.9 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	62 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants	85 Participants n=7 Participants	161 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard FB With Fluoroscopy n=109 Participants 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). 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 n=113 Participants 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. 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
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions Diagnostic	51 participants	62 participants
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions Non-Diagnostic	58 participants	51 participants

Adverse Events

Standard FB With Fluoroscopy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

R-EBUS With Ultrathin Bronchoscope

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard FB With Fluoroscopy n=109 participants at risk 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). 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 n=113 participants at risk 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. 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
Respiratory, thoracic and mediastinal disorders Adverse Event	5.5% 6/109 • Number of events 6 • 3 years It does not differ.	4.4% 5/113 • Number of events 5 • 3 years It does not differ.

Additional Information

Kate Taylor

Medical University of South Carolina

Phone: 843-792-2297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place