BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps
Condition: Adenoma Colon
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps
      using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new
      system for image-enhanced endoscopy using laser light, that is incorporated in the last
      generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes
      two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular
      microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by
      excitation.This system should enhance the microvascular pattern of superficial lesions,
      making the histological prediction easier.

      Aim of the study is to compare the accuracy of white light and BLI systems in real-time
      histology prediction of colonic polyps.

      For this purpose all colonscopies will be performed in a standard fashion using white light.
      When a polyps <10mm in size will be identified, patients will be randomized in two groups. In
      the Group 1 (White Light Grroup), all polyps <10mm will be evaluated with white light and
      prediction of histology (hyperplastic versus adenomatous) will be made by means of white
      light. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and
      scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band
      Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface
      pattern. The level of endoscopist's confidence in predicting histology (high or low
      confidence) for any polyp will be also recorded.

      Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative
      predictive values) will be calculated comparing endoscopist's prediction and pathology
      report, considered as reference standard in both study groups in order to evaluate the
      accuracy of real-time histology prediction by using BLI or white light.
    


Intervention name(s): BLI (Blue Laser Imaging)
Intervention type(s): Device
Intervention description(s): Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with at least one polyp <1 cm in size will be randomized in two groups. In the Group 1 (White Light Group), all polyps <10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE ( Narrow-band Imaging International Colorectal Endoscopic) classification. The level of endoscopist's confidence in predicting real-time histology (high or low confidence) for any polyp will be also recorded.
Masking: Single (Participant)
Primary purpose: Diagnostic