<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/NCT04489030</url>
  </required_header>
  <id_info>
    <org_study_id>SCH-NBI endoscopy</org_study_id>
    <nct_id>NCT04489030</nct_id>
  </id_info>
  <brief_title>Magnifying NBI Endoscopy for Gastric Condition</brief_title>
  <official_title>Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Recently, the improved resolution with standard endoscopy allows the close observation of&#xD;
      highly inflamed gastric mucosa without a magnifying view. In a previous study, the&#xD;
      investigators established the endoscopic classification of H. pylori-infected stomach by&#xD;
      non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal&#xD;
      patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was&#xD;
      91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous&#xD;
      gastric lesions between standard and magnifying endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard&#xD;
      endoscopy for predicting H. pylori-infection status and precancerous gastric conditions,&#xD;
      compared to magnifying NBI endoscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>H. pylori infection status</measure>
    <time_frame>1 month</time_frame>
    <description>H. pylori positivity would be assessed using rapid urease test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of chronic gastritis</measure>
    <time_frame>1 month</time_frame>
    <description>Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).</description>
  </primary_outcome>
  <enrollment type="Actual">254</enrollment>
  <condition>Gastritis H Pylori</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnifying narrow-band imaging endoscopy</intervention_name>
    <description>During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biospecimen would be obtained for urease test (commercial name: CLOtest) and pathological&#xD;
      analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a&#xD;
        single academic hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gastroscopy can be performed&#xD;
&#xD;
          -  H. pylori test and pathological analysis can be performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 20 or &gt; 70 years&#xD;
&#xD;
          -  Anemia (serum hemoglobin level &lt; 10 g/dL)&#xD;
&#xD;
          -  Severe systemic disease&#xD;
&#xD;
          -  Advanced chronic liver disease&#xD;
&#xD;
          -  Use of certain medications, including proton pump inhibitors, H2- receptor&#xD;
             antagonists, or antibiotics&#xD;
&#xD;
          -  History of H. pylori eradication&#xD;
&#xD;
          -  History of gastric surgery&#xD;
&#xD;
          -  Recent history of upper gastrointestinal bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun-Hyung Cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Digestive Disease Center, Soonchunhyang University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Jun-Hyung Cho</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastritis</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/NCT04489030
org study id: SCH-NBI endoscopy
nct id: NCT04489030
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recently, the improved resolution with standard endoscopy allows the close observation of
      highly inflamed gastric mucosa without a magnifying view. In a previous study, the
      investigators established the endoscopic classification of H. pylori-infected stomach by
      non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal
      patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was
      91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous
      gastric lesions between standard and magnifying endoscopy.
The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard
      endoscopy for predicting H. pylori-infection status and precancerous gastric conditions,
      compared to magnifying NBI endoscopy
observational model: Cohort
time perspective: Prospective
measure: H. pylori infection status
time frame: 1 month
description: H. pylori positivity would be assessed using rapid urease test.
measure: Degree of chronic gastritis
time frame: 1 month
description: Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).
intervention type: Other
intervention name: Magnifying narrow-band imaging endoscopy
description: During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
Biospecimen would be obtained for urease test (commercial name: CLOtest) and pathological
      analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jun-Hyung Cho, M.D.
role: Principal Investigator
affiliation: Digestive Disease Center, Soonchunhyang University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Jun-Hyung Cho
investigator title: Associate Professor
mesh term: Gastritis
sharing ipd: No