<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/NCT02982447</url>
  </required_header>
  <id_info>
    <org_study_id>Yangzhou1PH</org_study_id>
    <nct_id>NCT02982447</nct_id>
  </id_info>
  <brief_title>Comparison of Detection and Miss Rates of Blue Laser Imaging Versus Conventional White Light Colonoscopy</brief_title>
  <official_title>Comparison of Detection and Miss Rates of Colorectal Adenoma by Blue Laser Imaging (BLI) Versus Conventional White Light Colonoscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yangzhou No.1 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yangzhou No.1 People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for&#xD;
      use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal&#xD;
      method.comparison of detection and miss rates of BLI group Versus conventional White Light&#xD;
      Colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      blue laser imaging (BLI) are a new imaging systems used in endoscopy which are recently&#xD;
      developed. According to three recently published reports, the diagnostic ability of adenoma&#xD;
      characterization using blue laser imaging compares favorably with narrow band imaging. No&#xD;
      published data are available to date regarding adenoma detection with blue laser imaging.BLI&#xD;
      has the possibility to increase the detection of colorectal polyps by sufficient brightness&#xD;
      and clearer endoscopic images.The investigators recruited participants who underwent&#xD;
      colonoscopy for symptoms,screening,or surveillance.Participants were randomized for use of&#xD;
      either blue laser imaging (BLI) or conventional white light colonoscopy on withdrawal&#xD;
      method.Lesions detected on first-pass and second-pass examination were used for adenoma&#xD;
      detection and miss rates,respectively.The primary outcomes is to compare the adenoma and poly&#xD;
      detection rates of BLI with conventional white light Colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">April 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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">420</enrollment>
  <condition>Colorectal Adenoma</condition>
  <arm_group>
    <arm_group_label>Blue Laser Imaging colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional white light colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>blue laser imaging colonoscopy</intervention_name>
    <description>Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal</description>
    <arm_group_label>Blue Laser Imaging colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional white light colonoscopy</intervention_name>
    <description>In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.</description>
    <arm_group_label>conventional white light colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive patients who were underwent colonoscopy in our center for diagnostic work&#xD;
             up of colonic symptoms,surveillance of colorectal polyps, and colorectal cancer&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of colon cancer, colectomy familial adenomatous polyposis, or inflammatory&#xD;
             bowel diseases;&#xD;
&#xD;
          -  severe intestinal stenosis or obstruction;coagulation，disorders;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  and colonoscopy examinations with inadequate bowel cleanliness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhi jie hua, postgraduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Yangzhou</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhi jie hua, postgraduate</last_name>
    <phone>0086+87981199</phone>
    <email>prettycloud2@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First people's hospital of yangzhou</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhi jiehua, postgraduate</last_name>
      <phone>13921907913</phone>
      <email>prettycloud2@tom.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Yoshida N, Hisabe T, Inada Y, Kugai M, Yagi N, Hirai F, Yao K, Matsui T, Iwashita A, Kato M, Yanagisawa A, Naito Y. The ability of a novel blue laser imaging system for the diagnosis of invasion depth of colorectal neoplasms. J Gastroenterol. 2014 Jan;49(1):73-80. doi: 10.1007/s00535-013-0772-7. Epub 2013 Mar 15.</citation>
    <PMID>23494646</PMID>
  </reference>
  <results_reference>
    <citation>Yoshida N, Yagi N, Inada Y, Kugai M, Okayama T, Kamada K, Katada K, Uchiyama K, Ishikawa T, Handa O, Takagi T, Konishi H, Kokura S, Yanagisawa A, Naito Y. Ability of a novel blue laser imaging system for the diagnosis of colorectal polyps. Dig Endosc. 2014 Mar;26(2):250-8. doi: 10.1111/den.12127. Epub 2013 Jun 3.</citation>
    <PMID>23731034</PMID>
  </results_reference>
  <results_reference>
    <citation>Togashi K, Nemoto D, Utano K, Isohata N, Kumamoto K, Endo S, Lefor AK. Blue laser imaging endoscopy system for the early detection and characterization of colorectal lesions: a guide for the endoscopist. Therap Adv Gastroenterol. 2016 Jan;9(1):50-6. doi: 10.1177/1756283X15603614.</citation>
    <PMID>26770267</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yangzhou No.1 People's Hospital</investigator_affiliation>
    <investigator_full_name>zhi jie-hua</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>blue laser imaging,detection,randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT02982447
org study id: Yangzhou1PH
nct id: NCT02982447
lead sponsor: 
has dmc: Yes
It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for
      use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal
      method.comparison of detection and miss rates of BLI group Versus conventional White Light
      Colonoscopy.
blue laser imaging (BLI) are a new imaging systems used in endoscopy which are recently
      developed. According to three recently published reports, the diagnostic ability of adenoma
      characterization using blue laser imaging compares favorably with narrow band imaging. No
      published data are available to date regarding adenoma detection with blue laser imaging.BLI
      has the possibility to increase the detection of colorectal polyps by sufficient brightness
      and clearer endoscopic images.The investigators recruited participants who underwent
      colonoscopy for symptoms,screening,or surveillance.Participants were randomized for use of
      either blue laser imaging (BLI) or conventional white light colonoscopy on withdrawal
      method.Lesions detected on first-pass and second-pass examination were used for adenoma
      detection and miss rates,respectively.The primary outcomes is to compare the adenoma and poly
      detection rates of BLI with conventional white light Colonoscopy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy
time frame: 6 months
measure: comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy
time frame: 6 months
arm group label: Blue Laser Imaging colonoscopy
arm group type: Active Comparator
description: Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal
arm group label: conventional white light colonoscopy
arm group type: Experimental
description: In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
intervention type: Device
intervention name: blue laser imaging colonoscopy
description: Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal
arm group label: Blue Laser Imaging colonoscopy
intervention type: Device
intervention name: conventional white light colonoscopy
description: In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
arm group label: conventional white light colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: zhi jie hua, postgraduate
role: Principal Investigator
affiliation: First People's Hospital of Yangzhou
last name: zhi jie hua, postgraduate
phone: 0086+87981199
email: prettycloud2@sohu.com
facility: 
status: Recruiting
contact: 
country: China
citation: Yoshida N, Hisabe T, Inada Y, Kugai M, Yagi N, Hirai F, Yao K, Matsui T, Iwashita A, Kato M, Yanagisawa A, Naito Y. The ability of a novel blue laser imaging system for the diagnosis of invasion depth of colorectal neoplasms. J Gastroenterol. 2014 Jan;49(1):73-80. doi: 10.1007/s00535-013-0772-7. Epub 2013 Mar 15.
PMID: 23494646
citation: Yoshida N, Yagi N, Inada Y, Kugai M, Okayama T, Kamada K, Katada K, Uchiyama K, Ishikawa T, Handa O, Takagi T, Konishi H, Kokura S, Yanagisawa A, Naito Y. Ability of a novel blue laser imaging system for the diagnosis of colorectal polyps. Dig Endosc. 2014 Mar;26(2):250-8. doi: 10.1111/den.12127. Epub 2013 Jun 3.
PMID: 23731034
citation: Togashi K, Nemoto D, Utano K, Isohata N, Kumamoto K, Endo S, Lefor AK. Blue laser imaging endoscopy system for the early detection and characterization of colorectal lesions: a guide for the endoscopist. Therap Adv Gastroenterol. 2016 Jan;9(1):50-6. doi: 10.1177/1756283X15603614.
PMID: 26770267
responsible party type: Principal Investigator
investigator affiliation: Yangzhou No.1 People's Hospital
investigator full name: zhi jie-hua
investigator title: Principal Investigator
mesh term: Adenoma
sharing ipd: Undecided