<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/NCT03272945</url>
  </required_header>
  <id_info>
    <org_study_id>LCI</org_study_id>
    <nct_id>NCT03272945</nct_id>
  </id_info>
  <brief_title>Linked-color Imaging for the Detection of Colorectal Flat Lesions</brief_title>
  <official_title>Linked-color Imaging Versus White Light for the Detection of Colorectal Flat Lesions: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Showa Inan General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Showa Inan General 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>
      Linked color imaging (LCI) was recently developed and uses a laser endoscopic system&#xD;
      (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band&#xD;
      short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new&#xD;
      image-enhancing technology that is intended to enhance slight color differences in the red&#xD;
      region of the mucosa. The acquired color information is reallocated to differentiate colors&#xD;
      that are similar to the mucosal color, resulting in improved performance in depicting blood&#xD;
      vessels, and additional image processing that enhances color separation for red color permits&#xD;
      clear visualization of red blood vessels and white pits. This modality may increase the&#xD;
      detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels.&#xD;
      In addition, it has been reported that LCI increases the visibility of colorectal flat&#xD;
      lesions and contributes to improvement of the detection rate for these lesions. The primary&#xD;
      aim of the current study was to compare the detection rate of colorectal flat lesions of LCI&#xD;
      cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In&#xD;
      addition, we prospectively compared LCI and WL with regard to the visibility of colorectal&#xD;
      flat lesions found in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average prevalence of flat lesion /patient detected</measure>
    <time_frame>procedure</time_frame>
    <description>The total number of flat colorectal lesion/patient was defined. The average prevalence of flat lesion /patient detected was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>procedure</time_frame>
    <description>Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>procedure</time_frame>
    <description>Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The visibility of colorectal flat lesions</measure>
    <time_frame>1 day</time_frame>
    <description>Six endoscopists interpreted the images of CLI and WL. By using a previously reported visibility scale, we scored the visibility level on a scale of 1 to 4 and compared the two groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Colonic Polyp</condition>
  <arm_group>
    <arm_group_label>LCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using Linked-color imaging (LCI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using white light (WL).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Linked-color imaging</intervention_name>
    <description>Linked-color imaging colonoscopy</description>
    <arm_group_label>LCI</arm_group_label>
    <arm_group_label>WL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We enrolled consecutive patients who were referred for colonoscopy to our hospital for&#xD;
             diagnostic work up of colonic symptoms, surveillance of colorectal polyps, and&#xD;
             colorectal cancer screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  familial colorectal cancer syndrome including familial adenomatous polyposis and&#xD;
             hereditary non-polyposis colorectal cancer syndrome, personal history of colorectal&#xD;
             cancer or inflammatory bowel disease and those who had previous colonic resection.&#xD;
&#xD;
        Patients who were considered to be unsafe for polypectomy, including patients with bleeding&#xD;
        tendency and those with severe comorbid illnesses, were excluded. Those in whom &lt;90% of&#xD;
        mucosa was seen due to mixture of semisolid and solid colonic contents were also excluded&#xD;
        because of poor bowel preparation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akira Horiuchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Showa Inan General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Showa Inan General hospital</name>
      <address>
        <city>Komagane</city>
        <state>Nagano</state>
        <zip>399-4191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Showa Inan General Hospital</investigator_affiliation>
    <investigator_full_name>Akira Horiuchi</investigator_full_name>
    <investigator_title>Chief of Digestive Disease Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03272945
org study id: LCI
nct id: NCT03272945
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Linked color imaging (LCI) was recently developed and uses a laser endoscopic system
      (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band
      short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new
      image-enhancing technology that is intended to enhance slight color differences in the red
      region of the mucosa. The acquired color information is reallocated to differentiate colors
      that are similar to the mucosal color, resulting in improved performance in depicting blood
      vessels, and additional image processing that enhances color separation for red color permits
      clear visualization of red blood vessels and white pits. This modality may increase the
      detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels.
      In addition, it has been reported that LCI increases the visibility of colorectal flat
      lesions and contributes to improvement of the detection rate for these lesions. The primary
      aim of the current study was to compare the detection rate of colorectal flat lesions of LCI
      cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In
      addition, we prospectively compared LCI and WL with regard to the visibility of colorectal
      flat lesions found in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Average prevalence of flat lesion /patient detected
time frame: procedure
description: The total number of flat colorectal lesion/patient was defined. The average prevalence of flat lesion /patient detected was calculated.
measure: Adenoma detection rate
time frame: procedure
description: Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.
measure: Polyp detection rate
time frame: procedure
description: Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.
measure: The visibility of colorectal flat lesions
time frame: 1 day
description: Six endoscopists interpreted the images of CLI and WL. By using a previously reported visibility scale, we scored the visibility level on a scale of 1 to 4 and compared the two groups.
arm group label: LCI
arm group type: Experimental
description: Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using Linked-color imaging (LCI).
arm group label: WL
arm group type: Placebo Comparator
description: Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using white light (WL).
intervention type: Procedure
intervention name: Linked-color imaging
description: Linked-color imaging colonoscopy
arm group label: LCI
arm group label: WL
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Akira Horiuchi, MD
role: Principal Investigator
affiliation: Showa Inan General Hospital
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Showa Inan General Hospital
investigator full name: Akira Horiuchi
investigator title: Chief of Digestive Disease Center
mesh term: Colonic Polyps
sharing ipd: Undecided