<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/NCT01725321</url>
  </required_header>
  <id_info>
    <org_study_id>NBI_1</org_study_id>
    <nct_id>NCT01725321</nct_id>
  </id_info>
  <brief_title>Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps</brief_title>
  <official_title>Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the&#xD;
      missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in&#xD;
      the right side colon have been suggested to be the cause for interval cancer that developed&#xD;
      after a prior negative colonoscopy.&#xD;
&#xD;
      Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been&#xD;
      developed to improve colonic polyp detection. However, it remains controversial whether the&#xD;
      previous version of NBI helps to improve colonic polyp detection. The new generation&#xD;
      colonoscope is equipped with high definition and improved narrow band imaging (NBI) which&#xD;
      gives at least twice the viewable distance and contrast. The images obtained are far brighter&#xD;
      with better resolution than the previous version. It however remains to be determined whether&#xD;
      this enhanced imaging technique could help to improve colonic polyps detection.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The new generation NBI increases the detection rate of proximal serrated polyps and reduces&#xD;
      the missed rate of all colorectal polyps.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
        -  To determine whether the new generation NBI improve the detection rate of proximal&#xD;
           serrated polyps.&#xD;
&#xD;
        -  To determine whether the new generation NBI improve the detection rate of all colorectal&#xD;
           adenoma and polyps.&#xD;
&#xD;
        -  To determine whether the new generation NBI reduce the miss rate of colorectal adenoma&#xD;
           and polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design:&#xD;
&#xD;
      Prospective randomized trial&#xD;
&#xD;
      Inclusion:&#xD;
&#xD;
      • All patients scheduled to have screening or scheduled colonoscopy&#xD;
&#xD;
      Exclusion:&#xD;
&#xD;
        -  History of Crohn's or ulcerative colitis&#xD;
&#xD;
        -  Surveillance for known polyposis syndrome (FAP or HNPCC)&#xD;
&#xD;
        -  Previous colonic resection (except appendectomy)&#xD;
&#xD;
        -  Refused consent&#xD;
&#xD;
        -  Deranged coagulation profile that preclude polypectomy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection rate of proximal serrated polyp</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>No. of patients with proximal serrated polyps</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Missed rate for proximal serrated polyps</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Missing rate for proximal serrated polyps</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>during colonoscopy</time_frame>
    <description>No. of patients with adenoma detected</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">360</enrollment>
  <condition>Colonic Neoplasm</condition>
  <arm_group>
    <arm_group_label>Narrow band imaging</arm_group_label>
    <description>Colonoscopy with new narrow band imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Narrow band imaging</intervention_name>
    <description>Colonoscopy with new narrow band imaging</description>
    <arm_group_label>Narrow band imaging</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled to have colonoscopy for screening, surveillance or symptoms&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients scheduled to have colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Crohn's or ulcerative colitis&#xD;
&#xD;
          -  Surveillance for known polyposis syndrome (FAP or HNPCC)&#xD;
&#xD;
          -  Previous colonic resection (except appendectomy)&#xD;
&#xD;
          -  Refused consent&#xD;
&#xD;
          -  Deranged coagulation profile that preclude polypectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wai Keung Leung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>LEUNG Wai Keung</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>colonic adenoma</keyword>
  <keyword>serrated polyps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01725321
org study id: NBI_1
nct id: NCT01725321
lead sponsor: 
has dmc: No
Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the
      missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in
      the right side colon have been suggested to be the cause for interval cancer that developed
      after a prior negative colonoscopy.

      Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been
      developed to improve colonic polyp detection. However, it remains controversial whether the
      previous version of NBI helps to improve colonic polyp detection. The new generation
      colonoscope is equipped with high definition and improved narrow band imaging (NBI) which
      gives at least twice the viewable distance and contrast. The images obtained are far brighter
      with better resolution than the previous version. It however remains to be determined whether
      this enhanced imaging technique could help to improve colonic polyps detection.

      Hypothesis:

      The new generation NBI increases the detection rate of proximal serrated polyps and reduces
      the missed rate of all colorectal polyps.

      Aims:

        -  To determine whether the new generation NBI improve the detection rate of proximal
           serrated polyps.

        -  To determine whether the new generation NBI improve the detection rate of all colorectal
           adenoma and polyps.

        -  To determine whether the new generation NBI reduce the miss rate of colorectal adenoma
           and polyps.
Design:

      Prospective randomized trial

      Inclusion:

      • All patients scheduled to have screening or scheduled colonoscopy

      Exclusion:

        -  History of Crohn's or ulcerative colitis

        -  Surveillance for known polyposis syndrome (FAP or HNPCC)

        -  Previous colonic resection (except appendectomy)

        -  Refused consent

        -  Deranged coagulation profile that preclude polypectomy
observational model: Cohort
time perspective: Prospective
measure: Detection rate of proximal serrated polyp
time frame: During colonoscopy
description: No. of patients with proximal serrated polyps
measure: Missed rate for proximal serrated polyps
time frame: During colonoscopy
description: Missing rate for proximal serrated polyps
measure: Adenoma detection rate
time frame: during colonoscopy
description: No. of patients with adenoma detected
arm group label: Narrow band imaging
description: Colonoscopy with new narrow band imaging
intervention type: Other
intervention name: Narrow band imaging
description: Colonoscopy with new narrow band imaging
arm group label: Narrow band imaging
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wai Keung Leung, MD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: LEUNG Wai Keung
investigator title: Clinical Professor
mesh term: Colonic Neoplasms