Trial Outcomes & Findings for Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy (NCT NCT01676012)

Results Overview

Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

one year

Results posted on

2015-05-12

Participant Flow

Bronchoscopy will be performed in a standardized order using five different imaging modes.

Participant milestones

Participant milestones
Measure	Five Types of Bronchoscopy 1. Standard white light videobronchoscopy (WLB) 2. High Definition -Bronchoscopy 3. HD-bronchoscopy + surface enhancement (iScan-surface) 4. HD-bronchoscopy + tone enhancement (iScan-tone) 5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
Overall Study STARTED	32
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Five Types of Bronchoscopy 1. Standard white light videobronchoscopy (WLB) 2. High Definition -Bronchoscopy 3. HD-bronchoscopy + surface enhancement (iScan-surface) 4. HD-bronchoscopy + tone enhancement (iScan-tone) 5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
Overall Study Adverse Event	2
Overall Study incomplete set of videos	1

Baseline Characteristics

Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Five Types of Bronchoscopy n=29 Participants Bronchoscopy will be performed in a standardized order using five different imaging modes. 1. Standard white light videobronchoscopy (WLB) 2. High Definition -Bronchoscopy 3. HD-bronchoscopy + surface enhancement (iScan-surface) 4. HD-bronchoscopy + tone enhancement (iScan-tone) 5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Netherlands	29 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.

Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.

Outcome measures

Outcome measures
Measure	Five Types of Bronchoscopy n=29 Participants Bronchoscopy will be performed in a standardized order using five different imaging modes. 1. Standard white light videobronchoscopy (WLB) 2. High Definition -Bronchoscopy 3. HD-bronchoscopy + surface enhancement (iScan-surface) 4. HD-bronchoscopy + tone enhancement (iScan-tone) 5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
Sensitivity HD	0.72 # vascular sites detected per patient Standard Error 0.17
Sensitivity standard white light	0.28 # vascular sites detected per patient Standard Error 0.08
Sensitivity HD-i-scan1	0.78 # vascular sites detected per patient Standard Error 0.22
Sensitivity Hd-i-scan2	1.33 # vascular sites detected per patient Standard Error 0.29
Sensitivity AFB	0.12 # vascular sites detected per patient Standard Error 0.05

SECONDARY outcome

Timeframe: one year

When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.

Outcome measures

Outcome data not reported

Adverse Events

Five Types of Bronchoscopy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Five Types of Bronchoscopy n=29 participants at risk Bronchoscopy will be performed in a standardized order using five different imaging modes. 1. Standard white light videobronchoscopy (WLB) 2. High Definition -Bronchoscopy 3. HD-bronchoscopy + surface enhancement (iScan-surface) 4. HD-bronchoscopy + tone enhancement (iScan-tone) 5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
Respiratory, thoracic and mediastinal disorders vocal cord pathology	3.4% 1/29 • Number of events 1 • 11 months
Respiratory, thoracic and mediastinal disorders prolonged hospitalisiation	3.4% 1/29 • Number of events 1 • 11 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erik van der Heijden

Radboudumc

Phone: 0031243614579

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place