<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/NCT03279783</url>
  </required_header>
  <id_info>
    <org_study_id>341/2017</org_study_id>
    <nct_id>NCT03279783</nct_id>
  </id_info>
  <brief_title>LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon</brief_title>
  <official_title>LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon</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>
      Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a&#xD;
      significant adenoma miss rate still exists, particularly in the right colon. Optimizing the&#xD;
      detection of adenomas and sessile serrated lesions in the right colon is crucial to increase&#xD;
      the effectiveness of colonoscopy in colorectal cancer prevention.&#xD;
&#xD;
      Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently&#xD;
      developed technology that differentiates the red colour spectrum more effectively than White&#xD;
      Light imaging thanks to its optimal pre-process composition of light spectrum and advanced&#xD;
      signal processing. The increased colour contrast results in more accurate delineation of&#xD;
      abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that&#xD;
      LCI may be improve the detection of neoplastic lesion of colon.&#xD;
&#xD;
      The investigators performe a tandem prospective study to compare the right colon adenoma miss&#xD;
      rates of LCI colonoscopy with those of conventional white light colonoscopy.&#xD;
&#xD;
      Therefore participants scheduled for colonoscopy for the assessment of symptoms or for&#xD;
      colorectal cancer screening/surveillance receive the examination of the right colon twice, in&#xD;
      a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly&#xD;
      assigned (1:1), via computer-generated randomisation with block size of 20, to which&#xD;
      procedure is done first. The endoscopist are masked to group allocation until immediately&#xD;
      before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700&#xD;
      (EC-760R, EC-760ZP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">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>Sequential Assignment</intervention_model>
    <intervention_model_description>Participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back-to-back fashion, with standard white light (WL) and with LCI (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right colon adenoma miss rate</measure>
    <time_frame>One year</time_frame>
    <description>Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right colon advanced adenomas (size&gt;1 cm and/or high grade displasia and/or villous component) miss rate</measure>
    <time_frame>One year</time_frame>
    <description>Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right colon sessile serrated lesions miss rate</measure>
    <time_frame>One year</time_frame>
    <description>Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">752</enrollment>
  <condition>Adenoma Colon Polyp</condition>
  <arm_group>
    <arm_group_label>WLI (White light Imaging)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LCI (Linked Color Imaging)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LCI (Linked color imaging)</intervention_name>
    <description>Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)</description>
    <arm_group_label>LCI (Linked Color Imaging)</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 recetion&#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>
  <location>
    <facility>
      <name>Gastroenterology Unit, Valduce Hospital</name>
      <address>
        <city>Como</city>
        <zip>22100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franco Radaelli, MD</last_name>
      <phone>0039031324145</phone>
      <email>francoradaelli01@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</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>Head of 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/NCT03279783
org study id: 341/2017
nct id: NCT03279783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a
      significant adenoma miss rate still exists, particularly in the right colon. Optimizing the
      detection of adenomas and sessile serrated lesions in the right colon is crucial to increase
      the effectiveness of colonoscopy in colorectal cancer prevention.

      Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently
      developed technology that differentiates the red colour spectrum more effectively than White
      Light imaging thanks to its optimal pre-process composition of light spectrum and advanced
      signal processing. The increased colour contrast results in more accurate delineation of
      abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that
      LCI may be improve the detection of neoplastic lesion of colon.

      The investigators performe a tandem prospective study to compare the right colon adenoma miss
      rates of LCI colonoscopy with those of conventional white light colonoscopy.

      Therefore participants scheduled for colonoscopy for the assessment of symptoms or for
      colorectal cancer screening/surveillance receive the examination of the right colon twice, in
      a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly
      assigned (1:1), via computer-generated randomisation with block size of 20, to which
      procedure is done first. The endoscopist are masked to group allocation until immediately
      before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700
      (EC-760R, EC-760ZP).
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back-to-back fashion, with standard white light (WL) and with LCI (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.
primary purpose: Diagnostic
masking: Single (Participant)
measure: Right colon adenoma miss rate
time frame: One year
description: Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection
measure: Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate
time frame: One year
description: Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection
measure: Right colon sessile serrated lesions miss rate
time frame: One year
description: Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection
arm group label: WLI (White light Imaging)
arm group type: No Intervention
description: Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.
arm group label: LCI (Linked Color Imaging)
arm group type: Active Comparator
description: Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).
intervention type: Device
intervention name: LCI (Linked color imaging)
description: Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)
arm group label: LCI (Linked Color Imaging)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Valduce Hospital
investigator full name: Franco Radaelli
investigator title: Head of Endoscopy Unit
mesh term: Adenoma
sharing ipd: No