<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/NCT04411589</url>
  </required_header>
  <id_info>
    <org_study_id>2018SDU-QILU-125</org_study_id>
    <nct_id>NCT04411589</nct_id>
  </id_info>
  <brief_title>The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System</brief_title>
  <official_title>Evaluation of the Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System in Early Gastric Cancer and Intraepithelial Neoplasia: a Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to valuation of the diagnostic ability of white light imaging&#xD;
      and magnifying endoscopy with optical enhancement system in early gastric cancer and&#xD;
      intraepithelial neoplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stomach cancer is the second most common cause of cancer death. Endoscopic identification and&#xD;
      treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential&#xD;
      to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging&#xD;
      (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic&#xD;
      visualization of EGCs has a high rate of interobserver variability and correlates poorly with&#xD;
      the histological findings. For this reason, diagnosis has been based mostly on repeated&#xD;
      endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE)&#xD;
      system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE&#xD;
      system is the newly developed image-enhanced endoscopic technology, which combines high&#xD;
      definition white light endoscopy (WLE) and optical filters that limit the spectral&#xD;
      characteristics of the illumination light. The optical filters can achieve higher overall&#xD;
      transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a&#xD;
      continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal&#xD;
      structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying&#xD;
      endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is&#xD;
      conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the&#xD;
      diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is&#xD;
      superior to WLE in the detection rate and diagnostic efficiency of EGCs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>detection rate of GIN and EGC</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity, specificity of diagnostic performances of GIN and EGC</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>positive predictive value of diagnostic performances of GIN and EGC</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>negative predictive value of diagnostic performances of GIN and EGC</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diagnostic accuracy in a per-biopsy analysis</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Magnifying endoscopy with optical enhancement system group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>white light endoscopy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group go through gastroscopy under white light endoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>magnifying endoscopy with optical enhancement system</intervention_name>
    <description>A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.</description>
    <arm_group_label>Magnifying endoscopy with optical enhancement system group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>white light endoscopy system</intervention_name>
    <description>A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.</description>
    <arm_group_label>white light endoscopy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-80 years with H. pylori infection or histologically verified gastric&#xD;
             lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC)&#xD;
&#xD;
          -  Or patients aged 40-80 years from a region with high incidence of gastric cancer&#xD;
&#xD;
          -  Or patients aged 40-80 years with first-degree relative of patients with gastric&#xD;
             cancer&#xD;
&#xD;
          -  Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or&#xD;
             pickle diet or smoking or heavy drinking)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of gastrectomy&#xD;
&#xD;
          -  Active gastrointestinal bleeding or advanced gastric carcinoma&#xD;
&#xD;
          -  Coagulopathy or severe underlying diseases&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Absence of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqing Li, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University Qilu hosipital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanqing Li, MD, PhD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqing Li, PHD</last_name>
      <phone>86-531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 23, 2020</last_update_submitted>
  <last_update_submitted_qc>September 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>doctoral supervisor of Qilu Hospital gastroenterology department</investigator_title>
  </responsible_party>
  <keyword>Early gastric cancer, Optical enhancement system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT04411589
org study id: 2018SDU-QILU-125
nct id: NCT04411589
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to valuation of the diagnostic ability of white light imaging
      and magnifying endoscopy with optical enhancement system in early gastric cancer and
      intraepithelial neoplasia.
Stomach cancer is the second most common cause of cancer death. Endoscopic identification and
      treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential
      to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging
      (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic
      visualization of EGCs has a high rate of interobserver variability and correlates poorly with
      the histological findings. For this reason, diagnosis has been based mostly on repeated
      endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE)
      system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE
      system is the newly developed image-enhanced endoscopic technology, which combines high
      definition white light endoscopy (WLE) and optical filters that limit the spectral
      characteristics of the illumination light. The optical filters can achieve higher overall
      transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a
      continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal
      structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying
      endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is
      conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the
      diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is
      superior to WLE in the detection rate and diagnostic efficiency of EGCs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: detection rate of GIN and EGC
time frame: 3 months
description: The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.
measure: sensitivity, specificity of diagnostic performances of GIN and EGC
time frame: 3 months
measure: positive predictive value of diagnostic performances of GIN and EGC
time frame: 3 months
measure: negative predictive value of diagnostic performances of GIN and EGC
time frame: 3 months
measure: diagnostic accuracy in a per-biopsy analysis
time frame: 3 months
arm group label: Magnifying endoscopy with optical enhancement system group
arm group type: Experimental
description: Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.
arm group label: white light endoscopy group
arm group type: Active Comparator
description: Patients in this group go through gastroscopy under white light endoscopy.
intervention type: Device
intervention name: magnifying endoscopy with optical enhancement system
description: A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.
arm group label: Magnifying endoscopy with optical enhancement system group
intervention type: Device
intervention name: white light endoscopy system
description: A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.
arm group label: white light endoscopy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yanqing Li, MD, PhD
role: Principal Investigator
affiliation: Shandong University Qilu hosipital, China
last name: Yanqing Li, MD, PhD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: doctoral supervisor of Qilu Hospital gastroenterology department
mesh term: Stomach Neoplasms