HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study
Condition: Lungcancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways
      and pivotal for the diagnosis and staging of lung cancer. Further technological improvements
      have resulted in high definition (HD+) images and advanced image enhancement technique
      (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination
      with i-scan technology is superior to HD+WL (white light) for detecting endobronchial
      vascular changes. In this study we aim to correlate these vascular changes to histology and
      hypothesize that these vascular changes are related to (pre-) malignant changes and that the
      addition of i-scan is superior to HD+ WL.
    

Detailed description: 
      Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with
      Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will
      be performed by an experienced chest physician under local anaesthesia use and type of
      sedation following local protocol. Bronchoscopy will be performed in a standardized order
      using three different imaging modes. The order of the different modes will be randomized to
      avoid induced scope and / or cough lesion bias. High definition digital videos will be made
      from all procedures without in screen patient identification, but using a study code. The
      three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and
      HD+ surface enhancement and tone enhancement (TE-c, i-scan2).

      When sites with abnormal or suspicious vascular patterns are detected the investigator grade
      these findings using a visual classification scale [adapted from Herth JTO 2009 & Zaric Med
      Oncol 2013] and change to a regular bronchoscope and take biopsies from each site and a
      biopsy from a normal secondary carina on the contralateral site as control. Finally any other
      indicated procedures will be performed at the discretion of the local investigator.
    

Intervention name(s): Pentax EB-1990i HD-bronchoscope guided biopsy
Intervention type(s): Device
Intervention description(s): 3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree.
When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality [visual scale adapted from Herth 2009 and Zaric 2013] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with suspected or proven lung cancer are eligible if there is an indication for
        bronchoscopy. Eligible are patients with ASA physical status 1-3 and aged 18 years or
        older.
      
Biospecimen description: 
      biopsy of sites with abnormal or suspicious vascular patterns
    
Keywords: i-scan; histology