<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/NCT03824431</url>
  </required_header>
  <id_info>
    <org_study_id>39198813.4.0000.0068</org_study_id>
    <nct_id>NCT03824431</nct_id>
  </id_info>
  <brief_title>High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis</brief_title>
  <official_title>High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis-pHmetric , Esophageal Motility, Histological and Immunohistochemical Associative Findings With Endoscopic Microerosions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General 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>
      Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper&#xD;
      gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for&#xD;
      identification of abnormalities non detected in standard endoscopic exam. The high definition&#xD;
      endoscopy with NBI could achieve a more detailed mucosal evaluation, allowing distal&#xD;
      esophageal microerosions identification.&#xD;
&#xD;
      The objective was validate the presence and the meaning of distal esophageal mucosal&#xD;
      microerosions using high definition endoscopy and NBI through esophageal biopsy in&#xD;
      gastroesophageal reflux disease symptomatic patients and the association with GERD&#xD;
      physiopathology.&#xD;
&#xD;
      Seventy patients were selected from the gastroenterology outpatient clinic (University of Sao&#xD;
      Paulo Hospital) Endoscopic evaluation was sequentially performed after the pHmetry and&#xD;
      esophageal manometry. Esophageal mucosal biopsies were obtained following established&#xD;
      protocol for histological and immunohistochemical study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators focused the attention on patients with symptomatic GERD&#xD;
      according to inclusion criteria and used high definition endoscopy with NBI in an attempt to&#xD;
      increase the possibility of esophageal microerosion identification. The study was&#xD;
      complemented with examinations of esophageal phmetry. During endoscopy, esophageal biopsies&#xD;
      were obtained in patients with microerosions and controls (without microerosion). The&#xD;
      collected material was evaluated by histopathological and immunohistochemical methods&#xD;
      (interleukins-IL6, IL8 and IL1β) in an attempt to identify inflammatory alterations. The&#xD;
      results of this investigation could contribute to the evaluation of microerosions as an early&#xD;
      and significant abnormality with possible participation in the pathophysiology of GERD.&#xD;
&#xD;
      General objectives To validate the presence and clinical significance of endoscopic&#xD;
      microerosions in patients submitted to esophageal mucosal biopsies, with typical symptoms of&#xD;
      gastroesophageal reflux, using high definition endoscopy with (NBI), prolonged pHmetry,&#xD;
      histopathological and immuno- histochemistry.&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
        1. Validate the presence of microerosions in the distal esophagus, as found in&#xD;
           high-resolution endoscopy with NBI, in patients with typical symptoms of&#xD;
           Gastroesophageal Reflux Disease.&#xD;
&#xD;
        2. Verify the association of microerosions in the distal esophagus in high-resolution&#xD;
           endoscopy exams with NBI, with the manometric findings of esophageal perfusion&#xD;
           manometry.&#xD;
&#xD;
        3. To observe the changes in the prolonged pHmetry in patients with microerosions in the&#xD;
           distal esophagus through high definition endoscopy with NBI.&#xD;
&#xD;
        4. To evaluate the significance of the histological and immunohistochemical changes of&#xD;
           tissue specimens obtained in esophageal biopsies of patients with microerosions in the&#xD;
           distal esophagus, in high definition endoscopy with NBI.&#xD;
&#xD;
      This is a prospective, descriptive and cross-sectional study that included 90 patients, with&#xD;
      GERD complaints. Seventy patients were selected as the object of study according to&#xD;
      previously established inclusion and exclusion criteria. The selected patients were informed&#xD;
      about their participation and signed an informed consent term. The histopathology and&#xD;
      immunohistochemistry studies were carried out in the Department of Pathology of the same&#xD;
      institution.&#xD;
&#xD;
      The study patients were evaluated after selection according to the inclusion and exclusion&#xD;
      criteria on two occasions. On the first day, the examinations of esophageal manometry and&#xD;
      phmetria were performed. The next day the pHmetry probe was removed and then the high&#xD;
      definition endoscopy with NBI and the biopsies in the distal esophagus were performed. This&#xD;
      approach facilitated patient adherence, especially in relation to logistics in performing the&#xD;
      tests, and could represent more accurately the association of the tests performed. It was&#xD;
      previously established that incomplete data from the exams would lead to the exclusion of the&#xD;
      patient from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2014</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 4, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>High definition endoscopy with digital chromoscopy</measure>
    <time_frame>2 days</time_frame>
    <description>Presence or absence of microerosions in distal esophagus.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>GERD</condition>
  <arm_group>
    <arm_group_label>patients with endoscopic microerosions</arm_group_label>
    <description>==Patients with typical symptoms of Gastroesophageal Reflux Disease(GERD):&#xD;
1- High resolution definition with NBI endoscopic findings of mucosal microerosions in distal esophagus .&#xD;
.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients without microerosions</arm_group_label>
    <description>2- High resolution definition with NBI endoscopic without findings of mucosal microerosions in distal esophagus .</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Endoscopic esophageal biopsies</intervention_name>
    <arm_group_label>patients with endoscopic microerosions</arm_group_label>
    <arm_group_label>patients without microerosions</arm_group_label>
    <other_name>esophageal manometry</other_name>
    <other_name>esophageal phmetry</other_name>
    <other_name>esophageal biopsies</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients from the Gastroenterology Clinic (University of Sao Paulo)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients aged 18 to 70 years&#xD;
&#xD;
          -  Patients with symptoms typical of GERD, on at least two different days over a week,&#xD;
             for a period of at least three consecutive months, and with conventional upper&#xD;
             gastrointestinal endoscopy (UGE) without oesophageal changes, performed in the last 12&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hiatal hérnia&#xD;
&#xD;
          -  Ulcers of the upper digestive tract&#xD;
&#xD;
          -  Drugs that interfere with the physiology of the esophagus&#xD;
&#xD;
          -  Esophago-gastric surgeries&#xD;
&#xD;
          -  Achalasia of the esophagus&#xD;
&#xD;
          -  Esophagitis (erosive, eosinophilic, medicinal, infectious, non-erosive to conventional&#xD;
             endoscopy)&#xD;
&#xD;
          -  Esophageal stricture&#xD;
&#xD;
          -  Esophageal varices&#xD;
&#xD;
          -  Clinical situations that prevent more detailed evaluation of the Escamo-colunar&#xD;
             junction during endoscopy (psychomotor-agitation, cough)&#xD;
&#xD;
          -  Barrett's Esophagus&#xD;
&#xD;
          -  Esophageal diverticulum&#xD;
&#xD;
          -  Atrophic gastritis&#xD;
&#xD;
          -  Recent use of anti-inflammatories &lt;30 days&#xD;
&#xD;
          -  Systemic inflammatory / immune systemic diseases of the gastrointestinal tract&#xD;
&#xD;
          -  Recent Infectious Diseases &lt;30 days&#xD;
&#xD;
          -  BMI (Body Mass Index) &gt; 30 kg / m2&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Recent use of anticoagulants&#xD;
&#xD;
          -  Comorbidities that may interfere with esophageal motility&#xD;
&#xD;
          -  Recent use of PPI (Proton Pump Inhibitor) &lt;7 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Tomas Navarro Rodriguez</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Gastroesophageal reflux disease</keyword>
  <keyword>Narrow Band Imaging</keyword>
  <keyword>High definition endoscopy</keyword>
  <keyword>Microerosions</keyword>
  <keyword>Esophageal biopsy</keyword>
  <keyword>Immunohistochemistry.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</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/NCT03824431
org study id: 39198813.4.0000.0068
nct id: NCT03824431
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper
      gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for
      identification of abnormalities non detected in standard endoscopic exam. The high definition
      endoscopy with NBI could achieve a more detailed mucosal evaluation, allowing distal
      esophageal microerosions identification.

      The objective was validate the presence and the meaning of distal esophageal mucosal
      microerosions using high definition endoscopy and NBI through esophageal biopsy in
      gastroesophageal reflux disease symptomatic patients and the association with GERD
      physiopathology.

      Seventy patients were selected from the gastroenterology outpatient clinic (University of Sao
      Paulo Hospital) Endoscopic evaluation was sequentially performed after the pHmetry and
      esophageal manometry. Esophageal mucosal biopsies were obtained following established
      protocol for histological and immunohistochemical study.
In this study the investigators focused the attention on patients with symptomatic GERD
      according to inclusion criteria and used high definition endoscopy with NBI in an attempt to
      increase the possibility of esophageal microerosion identification. The study was
      complemented with examinations of esophageal phmetry. During endoscopy, esophageal biopsies
      were obtained in patients with microerosions and controls (without microerosion). The
      collected material was evaluated by histopathological and immunohistochemical methods
      (interleukins-IL6, IL8 and IL1β) in an attempt to identify inflammatory alterations. The
      results of this investigation could contribute to the evaluation of microerosions as an early
      and significant abnormality with possible participation in the pathophysiology of GERD.

      General objectives To validate the presence and clinical significance of endoscopic
      microerosions in patients submitted to esophageal mucosal biopsies, with typical symptoms of
      gastroesophageal reflux, using high definition endoscopy with (NBI), prolonged pHmetry,
      histopathological and immuno- histochemistry.

      Specific objectives

        1. Validate the presence of microerosions in the distal esophagus, as found in
           high-resolution endoscopy with NBI, in patients with typical symptoms of
           Gastroesophageal Reflux Disease.

        2. Verify the association of microerosions in the distal esophagus in high-resolution
           endoscopy exams with NBI, with the manometric findings of esophageal perfusion
           manometry.

        3. To observe the changes in the prolonged pHmetry in patients with microerosions in the
           distal esophagus through high definition endoscopy with NBI.

        4. To evaluate the significance of the histological and immunohistochemical changes of
           tissue specimens obtained in esophageal biopsies of patients with microerosions in the
           distal esophagus, in high definition endoscopy with NBI.

      This is a prospective, descriptive and cross-sectional study that included 90 patients, with
      GERD complaints. Seventy patients were selected as the object of study according to
      previously established inclusion and exclusion criteria. The selected patients were informed
      about their participation and signed an informed consent term. The histopathology and
      immunohistochemistry studies were carried out in the Department of Pathology of the same
      institution.

      The study patients were evaluated after selection according to the inclusion and exclusion
      criteria on two occasions. On the first day, the examinations of esophageal manometry and
      phmetria were performed. The next day the pHmetry probe was removed and then the high
      definition endoscopy with NBI and the biopsies in the distal esophagus were performed. This
      approach facilitated patient adherence, especially in relation to logistics in performing the
      tests, and could represent more accurately the association of the tests performed. It was
      previously established that incomplete data from the exams would lead to the exclusion of the
      patient from the study.
observational model: Case-Control
time perspective: Prospective
measure: High definition endoscopy with digital chromoscopy
time frame: 2 days
description: Presence or absence of microerosions in distal esophagus.
arm group label: patients with endoscopic microerosions
description: ==Patients with typical symptoms of Gastroesophageal Reflux Disease(GERD):
1- High resolution definition with NBI endoscopic findings of mucosal microerosions in distal esophagus .
.
arm group label: patients without microerosions
description: 2- High resolution definition with NBI endoscopic without findings of mucosal microerosions in distal esophagus .
intervention type: Diagnostic Test
intervention name: Endoscopic esophageal biopsies
arm group label: patients with endoscopic microerosions
arm group label: patients without microerosions
other name: esophageal manometry
other name: esophageal phmetry
other name: esophageal biopsies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Tomas Navarro Rodriguez
investigator title: Clinical Professor
mesh term: Esophagitis