<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/NCT01694511</url>
  </required_header>
  <id_info>
    <org_study_id>2-2188</org_study_id>
    <nct_id>NCT01694511</nct_id>
  </id_info>
  <brief_title>Endoscopic Detection of Dysplasia in Barrett's Esophagus</brief_title>
  <official_title>High Resolution Magnifying Endoscopy and Contrast Enhanced Imaging Versus Standard White Light Endoscopy for the Detection of Dysplasia in Barrett's Esophagus. A Prospective Blinded Cross-over Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether High Resolution Magnification Endoscopy&#xD;
      (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to&#xD;
      conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic&#xD;
      epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients&#xD;
      with Barrett's Esophagus (BE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BE is a metaplastic mucosal transformation adjacent to the esophagogastric junction, due to&#xD;
      chronic reflux of gastric juices, Gastro Esophageal Reflux Disease (GERD). The continuous&#xD;
      esophageal exposure of acid- and/or bile- containing fluids leads, untreated, to chronic&#xD;
      esophagitis. In certain patients a mucosal transformation takes place. The epithelium in the&#xD;
      distal part of esophagus is transferred from squamous into a more intestinal-like mucosa,&#xD;
      called Specialized Intestinal Metaplasia (SIM).Patients with BE is believed to run a higher&#xD;
      risk of developing esophageal adenocarcinoma (EAC).&#xD;
&#xD;
      EAC is a rare condition in the western society, but the prevalence is rising compared with&#xD;
      other malignancies, and a substantial increase has been seen during the last four decades.&#xD;
      The pathogenesis of cancer development is believed to be that SIM in some patients can&#xD;
      undergo dysplastic transformation, from low to high grade, and from high grade dysplasia&#xD;
      (HGD) develop into AC. Advanced EAC is associated to a poor prognosis whereas HGD or&#xD;
      carcinoma in situ may be treated endoscopically with a favorable outcome.&#xD;
&#xD;
      The need for surveillance endoscopy in order to discover early cancer lesions available to&#xD;
      curable treatment is up against cost effectiveness and evidence level regarding screening.&#xD;
      The conventional endoscopic (CE) surveillance algorithm for BE is standard WLE and 4 quadrant&#xD;
      biopsies of the metaplastic epithelium every 1-2 cm above the esophagogastric junction. The&#xD;
      development of advanced endoscopic techniques have made it possible to distinguish minimal&#xD;
      polypoid lesions but also the microvasculature and pit-pattern structures that in certain&#xD;
      grading systems have been associated to presence of dysplasia. Attempts have been made in&#xD;
      exploring the benefits of advanced endoscopic technologies against standard WLE.&#xD;
      Feasibility-studies suggests that the new techniques improves the biopsy-yield for dysplasia,&#xD;
      however only a limited number of prospective studies exist.&#xD;
&#xD;
      Study aim: To determine whether HRME and CVC with targeted biopsies is superior to&#xD;
      conventional WLE with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle&#xD;
      Protocol) for detection of pre-malignant lesions in patients with BE.&#xD;
&#xD;
      Primary endpoint: Incidence of detected dysplasia by each endoscopic technique. Secondary&#xD;
      endpoints: 1.The yield of low- and/or high-grade dysplasia by each endoscopic technique.&#xD;
      2.The number of biopsies taken and the duration of the different endoscopic techniques. 3.The&#xD;
      endoscopic prediction capability of present dysplasia compared to histopathology for HRME.&#xD;
&#xD;
      Statistical power: Based on the primary endpoint, the amount of dysplasia in a&#xD;
      Barrett-population is approximately 10%. We calculated a raise in positive yield with using&#xD;
      advanced endoscopy to 8%. At p&lt;0,05 and a power of 80% the need for 105 patients.&#xD;
&#xD;
      Setting: Tertiary referral high volume endoscopy center at Sahlgrenska University Hospital,&#xD;
      Sweden.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of detected dysplasia by each endoscopic technique.</measure>
    <time_frame>Up to 36 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The yield of low- and/or high-grade dysplasia by each endoscopic technique.</measure>
    <time_frame>Up to 36 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of biopsies taken and the duration of the different endoscopic techniques.</measure>
    <time_frame>Up to 36 months.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.</measure>
    <time_frame>Up to 36 months.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Barrett's Esophagus</condition>
  <arm_group>
    <arm_group_label>Introductory conventional endoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional endoscopy followed by HRME+CVC after 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Introductory HRME+CVC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HRME+CVC followed by conventional endoscopy after 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HRME+CVC</intervention_name>
    <description>High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy</description>
    <arm_group_label>Introductory conventional endoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional endoscopy</intervention_name>
    <description>Conventional white light endoscopy with four-quadrant biopsy</description>
    <arm_group_label>Introductory HRME+CVC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of specialized intestinal metaplasia in biopsies from the esophagus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dysplasia or cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders F Edebo, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dept. Gastrosurgical Research and Education, Inst. Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastrointestinal Endoscopy Unit, Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>S-41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>February 7, 2014</last_update_submitted>
  <last_update_submitted_qc>February 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopy, Gastrointestinal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</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/NCT01694511
org study id: 2-2188
nct id: NCT01694511
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether High Resolution Magnification Endoscopy
      (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to
      conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic
      epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients
      with Barrett's Esophagus (BE).
BE is a metaplastic mucosal transformation adjacent to the esophagogastric junction, due to
      chronic reflux of gastric juices, Gastro Esophageal Reflux Disease (GERD). The continuous
      esophageal exposure of acid- and/or bile- containing fluids leads, untreated, to chronic
      esophagitis. In certain patients a mucosal transformation takes place. The epithelium in the
      distal part of esophagus is transferred from squamous into a more intestinal-like mucosa,
      called Specialized Intestinal Metaplasia (SIM).Patients with BE is believed to run a higher
      risk of developing esophageal adenocarcinoma (EAC).

      EAC is a rare condition in the western society, but the prevalence is rising compared with
      other malignancies, and a substantial increase has been seen during the last four decades.
      The pathogenesis of cancer development is believed to be that SIM in some patients can
      undergo dysplastic transformation, from low to high grade, and from high grade dysplasia
      (HGD) develop into AC. Advanced EAC is associated to a poor prognosis whereas HGD or
      carcinoma in situ may be treated endoscopically with a favorable outcome.

      The need for surveillance endoscopy in order to discover early cancer lesions available to
      curable treatment is up against cost effectiveness and evidence level regarding screening.
      The conventional endoscopic (CE) surveillance algorithm for BE is standard WLE and 4 quadrant
      biopsies of the metaplastic epithelium every 1-2 cm above the esophagogastric junction. The
      development of advanced endoscopic techniques have made it possible to distinguish minimal
      polypoid lesions but also the microvasculature and pit-pattern structures that in certain
      grading systems have been associated to presence of dysplasia. Attempts have been made in
      exploring the benefits of advanced endoscopic technologies against standard WLE.
      Feasibility-studies suggests that the new techniques improves the biopsy-yield for dysplasia,
      however only a limited number of prospective studies exist.

      Study aim: To determine whether HRME and CVC with targeted biopsies is superior to
      conventional WLE with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle
      Protocol) for detection of pre-malignant lesions in patients with BE.

      Primary endpoint: Incidence of detected dysplasia by each endoscopic technique. Secondary
      endpoints: 1.The yield of low- and/or high-grade dysplasia by each endoscopic technique.
      2.The number of biopsies taken and the duration of the different endoscopic techniques. 3.The
      endoscopic prediction capability of present dysplasia compared to histopathology for HRME.

      Statistical power: Based on the primary endpoint, the amount of dysplasia in a
      Barrett-population is approximately 10%. We calculated a raise in positive yield with using
      advanced endoscopy to 8%. At p<0,05 and a power of 80% the need for 105 patients.

      Setting: Tertiary referral high volume endoscopy center at Sahlgrenska University Hospital,
      Sweden.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Incidence of detected dysplasia by each endoscopic technique.
time frame: Up to 36 months.
measure: The yield of low- and/or high-grade dysplasia by each endoscopic technique.
time frame: Up to 36 months.
measure: The number of biopsies taken and the duration of the different endoscopic techniques.
time frame: Up to 36 months.
measure: The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.
time frame: Up to 36 months.
arm group label: Introductory conventional endoscopy
arm group type: Active Comparator
description: Conventional endoscopy followed by HRME+CVC after 30 days.
arm group label: Introductory HRME+CVC
arm group type: Active Comparator
description: HRME+CVC followed by conventional endoscopy after 30 days.
intervention type: Procedure
intervention name: HRME+CVC
description: High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy
arm group label: Introductory conventional endoscopy
intervention type: Procedure
intervention name: conventional endoscopy
description: Conventional white light endoscopy with four-quadrant biopsy
arm group label: Introductory HRME+CVC
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anders F Edebo, MD, PhD
role: Study Director
affiliation: Dept. Gastrosurgical Research and Education, Inst. Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Barrett Esophagus