<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/NCT03011437</url>
  </required_header>
  <id_info>
    <org_study_id>2016A020212007</org_study_id>
    <nct_id>NCT03011437</nct_id>
  </id_info>
  <brief_title>Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging</brief_title>
  <official_title>Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kashgar 1st People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kashgar 1st People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori)&#xD;
      infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly&#xD;
      developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by&#xD;
      enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of&#xD;
      LCI for diagnosing H. pylori infection compared with WLI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections in&#xD;
      man. And it is the causative factor for peptic ulcer and regarded as a class I carcinogen for&#xD;
      gastric adenocarcinoma. Therefore, accurate detection of infection is crucial for devising&#xD;
      proper eradication regimens and preventing the more severe GI complications. Detection of H.&#xD;
      pylori in the gastric mucosa can be performed via (1) direct detection of the bacterium;&#xD;
      culture, histology and polymerase chain reaction or (2) indirect detection of its enzymatic&#xD;
      products particularly urease and serum H. pylori-specific antibody examinations. The direct&#xD;
      detection methods are complicated and time-consuming. While the indirect detection methods&#xD;
      are less accurate. With the wide use of endoscopy, diagnosis of H. pylori infection by&#xD;
      endoscopy should be more accurate and easily available. However, there are still lack of&#xD;
      endoscopic criteria for diagnosing H. pylori infection by conventional white light imaging&#xD;
      (WLI), which correlates poorly with histopathological findings of H. pylori-induced gastritis&#xD;
      . The newly modified LCI system (FUJIFILM Co.) can obtain clear and bright endoscopic images&#xD;
      by using short-wavelength narrow-band laser light combined with white laser light. LCI&#xD;
      technique can enhance the color of the endoscopic images by digital processing, which makes&#xD;
      red regions seem redder and white regions seem whiter. Therefore, LCI may facilitate the&#xD;
      detection of certain kinds of gastric lesions. As the common thinking, H. pylori-associated&#xD;
      gastritis regions are redder than normal mucosa under WLI because of hyperemia following&#xD;
      inflammation. And such redness can be enhanced by LCI. However, there is no criterion for&#xD;
      this estimating. Red, green and blue (RGB) color model is a basic component system of the&#xD;
      hue, of which each color is a composition of different proportions. Thus, the color obtained&#xD;
      by endoscopic images can be quantified by RGB model. The study aimed at comparing the ability&#xD;
      of WLI and LCI for diagnosing H. pylori infection by using RGB color model and investigating&#xD;
      objective and quantifiable endoscopic criteria for predicting H. pylori infection.&#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">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology</measure>
    <time_frame>one month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hp infection rate</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>cases</arm_group_label>
    <description>Patients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Esophagogastroduodenoscopy</intervention_name>
    <description>Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.</description>
    <arm_group_label>cases</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      gastric mucosa&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People who undergo esophagogastroduodenoscopy in the First People's Hospital of Kashgar&#xD;
        Region. All patients provided written informed consents to undergo&#xD;
        esophagogastroduodenoscopy and participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People who undergo esophagogastroduodenoscopy for possible upper gastrointestinal&#xD;
             disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have taken proton pump inhibitor, antibiotics, non-steroidal&#xD;
             anti-inflammatory drugs, bismuth agent, H2-receptor inhibitor and medicines that can&#xD;
             affect the test of H. pylori infection in a month&#xD;
&#xD;
          -  Patients with severe systematic disorders&#xD;
&#xD;
          -  Patients with accurate gastrointestinal bleeding in a week&#xD;
&#xD;
          -  Patients with histories of gastric surgery&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Patients with poor coagulation function&#xD;
&#xD;
          -  Patients diagnosed with gastric cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zou X Guang</last_name>
    <role>Study Chair</role>
    <affiliation>First People's Hospital of Kashgar Region</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bai Yang, Doctor</last_name>
    <phone>15626498226</phone>
    <email>baiyang1665@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First People's Hospital of Kashgar Region</name>
      <address>
        <city>Kashgar</city>
        <state>Xinjiang</state>
        <zip>0998</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bai Yang, Doctor</last_name>
      <phone>15626498226</phone>
      <email>baiyang1665@163.com</email>
    </contact>
    <investigator>
      <last_name>Bai Yang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kashgar 1st People's Hospital</investigator_affiliation>
    <investigator_full_name>Bai Yang</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>linked color imaging</keyword>
  <keyword>Helicobacter Pylori</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Helicobacter Infections</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/NCT03011437
org study id: 2016A020212007
nct id: NCT03011437
lead sponsor: 
has dmc: Yes
There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori)
      infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly
      developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by
      enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of
      LCI for diagnosing H. pylori infection compared with WLI.
Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections in
      man. And it is the causative factor for peptic ulcer and regarded as a class I carcinogen for
      gastric adenocarcinoma. Therefore, accurate detection of infection is crucial for devising
      proper eradication regimens and preventing the more severe GI complications. Detection of H.
      pylori in the gastric mucosa can be performed via (1) direct detection of the bacterium;
      culture, histology and polymerase chain reaction or (2) indirect detection of its enzymatic
      products particularly urease and serum H. pylori-specific antibody examinations. The direct
      detection methods are complicated and time-consuming. While the indirect detection methods
      are less accurate. With the wide use of endoscopy, diagnosis of H. pylori infection by
      endoscopy should be more accurate and easily available. However, there are still lack of
      endoscopic criteria for diagnosing H. pylori infection by conventional white light imaging
      (WLI), which correlates poorly with histopathological findings of H. pylori-induced gastritis
      . The newly modified LCI system (FUJIFILM Co.) can obtain clear and bright endoscopic images
      by using short-wavelength narrow-band laser light combined with white laser light. LCI
      technique can enhance the color of the endoscopic images by digital processing, which makes
      red regions seem redder and white regions seem whiter. Therefore, LCI may facilitate the
      detection of certain kinds of gastric lesions. As the common thinking, H. pylori-associated
      gastritis regions are redder than normal mucosa under WLI because of hyperemia following
      inflammation. And such redness can be enhanced by LCI. However, there is no criterion for
      this estimating. Red, green and blue (RGB) color model is a basic component system of the
      hue, of which each color is a composition of different proportions. Thus, the color obtained
      by endoscopic images can be quantified by RGB model. The study aimed at comparing the ability
      of WLI and LCI for diagnosing H. pylori infection by using RGB color model and investigating
      objective and quantifiable endoscopic criteria for predicting H. pylori infection.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology
time frame: one month
measure: Hp infection rate
time frame: one month
arm group label: cases
description: Patients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region.
intervention type: Other
intervention name: Esophagogastroduodenoscopy
description: Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.
arm group label: cases
gastric mucosa
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zou X Guang
role: Study Chair
affiliation: First People's Hospital of Kashgar Region
last name: Bai Yang, Doctor
phone: 15626498226
email: baiyang1665@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Kashgar 1st People's Hospital
investigator full name: Bai Yang
investigator title: Director
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Helicobacter Infections
sharing ipd: No