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

NCT01676012 | Completed Results

• 1 other identifier: 38719
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Through technological improvement a new technique has become available in the form of high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers only. The impact of this development with high-definition videobronchoscopy using a 1.1 megapixel chip on the diagnostic performance of bronchoscopy is however unknown. The aim of the present study therefore is to explore the diagnostic performance (sensitivity and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode SAFE3000 autofluorescence videobronchoscopy in a high risk population.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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.

  one year

Secondary Outcomes (1)

• Sensitivity and Specificity of HD Videobronchoscopy

  one year

Study Arms (1)

five types of bronchoscopy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected or proven head and neck or lung cancer fit for surgery and scheduled for diagnostic or therapeutic surgical procedure in the Radboud University Medical Center Nijmegen

You may qualify if:

• Patients fit for surgery and scheduled for diagnostic or therapeutic surgical procedure under general anesthesia by the cardiothoracic or thoracic surgeon or ENT surgeon with suspected or proven lung cancer or head and neck cancer.
• ASA physical status 1-3.
• Age 18 years or older.
• informed consent

You may not qualify if:

• Contraindications are all known contraindications for diagnostic bronchoscopy such as:
• bleeding disorders,
• indication for use of anticoagulant therapy (acenocoumarol, warfarins, therapeutic dose of low molecular weight heparins or clopidogrel),
• known allergy for lidocaine,
• known pulmonary hypertension,
• recent and/or uncontrolled cardiac disease. Presence of contraindications for the use of laryngeal mask (anatomical abnormalities) increased risk for intubation (mallampati score 4), or compromised upper airway due to extension of primary head and neck cancer.
• ASA classification greater than or equal to 4.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center Nijmegen

Nijmegen, Geert Grooteplein 10, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Erik van der Heijden
• Organization: Radboudumc

Erik.vanderHeijden@radboudumc.nl

0031243614579

Study Officials

• HFM vanderHeijden, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 30, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-05

Locations

NL (1)