<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274115</url>
  </required_header>
  <id_info>
    <org_study_id>341/2017 bis</org_study_id>
    <nct_id>NCT03274115</nct_id>
  </id_info>
  <brief_title>BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps</brief_title>
  <official_title>BLI (Blue Light Imaging) Application for the Histological Characterization of Colorectal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valduce Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Valduce Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps&#xD;
      using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new&#xD;
      system for image-enhanced endoscopy using laser light, that is incorporated in the last&#xD;
      generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes&#xD;
      two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular&#xD;
      microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by&#xD;
      excitation.This system should enhance the microvascular pattern of superficial lesions,&#xD;
      making the histological prediction easier.&#xD;
&#xD;
      Aim of the study is to compare the accuracy of white light and BLI systems in real-time&#xD;
      histology prediction of colonic polyps.&#xD;
&#xD;
      For this purpose all colonscopies will be performed in a standard fashion using white light.&#xD;
      When a polyps &lt;10mm in size will be identified, patients will be randomized in two groups. In&#xD;
      the Group 1 (White Light Grroup), all polyps &lt;10mm will be evaluated with white light and&#xD;
      prediction of histology (hyperplastic versus adenomatous) will be made by means of white&#xD;
      light. In the Group 2 (BLI Group) , all polyps &lt;10mm in size will be evaluated with BLI and&#xD;
      scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band&#xD;
      Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface&#xD;
      pattern. The level of endoscopist's confidence in predicting histology (high or low&#xD;
      confidence) for any polyp will be also recorded.&#xD;
&#xD;
      Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative&#xD;
      predictive values) will be calculated comparing endoscopist's prediction and pathology&#xD;
      report, considered as reference standard in both study groups in order to evaluate the&#xD;
      accuracy of real-time histology prediction by using BLI or white light.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients with at least one polyp &lt;1 cm in size will be randomized in two groups. In the Group 1 (White Light Group), all polyps &lt;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 &lt;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.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology</measure>
    <time_frame>one year</time_frame>
    <description>Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology will be calculated comparing endoscopist's prediction with pathology result (reference standard).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Adenoma Colon</condition>
  <arm_group>
    <arm_group_label>White Light (WL)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blue Light Imaging (BLI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BLI (Blue Laser Imaging)</intervention_name>
    <description>Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps</description>
    <arm_group_label>Blue Light Imaging (BLI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All outpatients referred for colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) &lt; 2 in one&#xD;
             colonic segment)&#xD;
&#xD;
          -  previous colonic resection&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  ereditary polyposic syndromes&#xD;
&#xD;
          -  patients on antithrombotics precluding polyp resection&#xD;
&#xD;
          -  absence of informed consent&#xD;
&#xD;
          -  inpatients or patients undergoing urgent colonscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franco Radaelli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Valduce Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology Unit, Valduce Hospital</name>
      <address>
        <city>Como</city>
        <zip>22100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Valduce Hospital</investigator_affiliation>
    <investigator_full_name>Franco Radaelli</investigator_full_name>
    <investigator_title>MD, Head of Gastrointestinal Endoscopy Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274115
org study id: 341/2017 bis
nct id: NCT03274115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology
time frame: one year
description: Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology will be calculated comparing endoscopist's prediction with pathology result (reference standard).
arm group label: White Light (WL)
arm group type: No Intervention
description: White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).
arm group label: Blue Light Imaging (BLI)
arm group type: Active Comparator
description: Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.
intervention type: Device
intervention name: BLI (Blue Laser Imaging)
description: Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps
arm group label: Blue Light Imaging (BLI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Franco Radaelli
role: Principal Investigator
affiliation: Valduce Hospital
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Valduce Hospital
investigator full name: Franco Radaelli
investigator title: MD, Head of Gastrointestinal Endoscopy Unit
mesh term: Adenoma
sharing ipd: No