<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/NCT03015571</url>
  </required_header>
  <id_info>
    <org_study_id>HT-001</org_study_id>
    <nct_id>NCT03015571</nct_id>
  </id_info>
  <brief_title>Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection</brief_title>
  <official_title>Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomasz Romańczyk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H-T. Centrum Medyczne Sp. z o.o. sp. k</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely&#xD;
      used during esophagus inspection at diagnostic gastroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heterotopic gastric mucosa, also called inlet patch, is area of ectopic gastric mucosa with&#xD;
      common location at proximal part of esophagus. Because of the location, lesions are likely to&#xD;
      be missed during routine gastroscopy. The clinical significance of inlet patches remains&#xD;
      unknown, however they may be symptomatic and may cause morphologic changes such as&#xD;
      strictures, ulcers, webs, stenoses or even adenocarcinomas. Moreover inlet patches may be&#xD;
      correlated with reflux symptoms up to 73,1%. Several studies were conducted to determine&#xD;
      whether NBI improves detection of cervical inlet patches, some of them were also prospective&#xD;
      studies, however no randomized study was conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">January 9, 2018</completion_date>
  <primary_completion_date type="Actual">January 9, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of heterotopic gastric mucosa in the proximal esophagus</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total and esophagus inspection time</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of other upper gastrointestinal lesions</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of throat and esophageal reflux symptoms with cervical inlet patches</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Heterotopic Gastric Mucosa of the Proximal Esophagus</condition>
  <arm_group>
    <arm_group_label>NBI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Narrow Band Imaging with regular care of cervical inlet patches detection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Use of High Definition White Light (WL) with regular care of cervical inlet patches detection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NBI increased care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Narrow Band Imaging with increased care of cervical inlet patches detection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL increased care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Use of High Definition White Light (WL) with increased care of cervical inlet patches detection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Esophagus inspection in Narrow Band imaging.</intervention_name>
    <description>During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection.</description>
    <arm_group_label>NBI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard High definition endoscopy.</intervention_name>
    <description>Whole procedure will be performed in standard High definition endoscopy.</description>
    <arm_group_label>WL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Esophagus inspection in Narrow Band imaging and increased care.</intervention_name>
    <description>During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection and with increased care of cervical inlet patches detection.</description>
    <arm_group_label>NBI increased care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard High definition endoscopy and increased care.</intervention_name>
    <description>Whole procedure will be performed in standard High definition endoscopy with increased care of cervical inlet patches detection.</description>
    <arm_group_label>WL increased care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referral for diagnostic gastroscopy&#xD;
&#xD;
          -  Ability to undergo diagnostic gastroscopy&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Gastroscopy with treatment procedure&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>H-T.Centrum Medyczne Sp. z o.o. Sp. K.</name>
      <address>
        <city>Tychy</city>
        <state>Silesia</state>
        <zip>43-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.</citation>
    <PMID>15056100</PMID>
  </reference>
  <reference>
    <citation>Maconi G, Pace F, Vago L, Carsana L, Bargiggia S, Bianchi Porro G. Prevalence and clinical features of heterotopic gastric mucosa in the upper oesophagus (inlet patch). Eur J Gastroenterol Hepatol. 2000 Jul;12(7):745-9. doi: 10.1097/00042737-200012070-00005.</citation>
    <PMID>10929900</PMID>
  </reference>
  <reference>
    <citation>Chong VH. Clinical significance of heterotopic gastric mucosal patch of the proximal esophagus. World J Gastroenterol. 2013 Jan 21;19(3):331-8. doi: 10.3748/wjg.v19.i3.331.</citation>
    <PMID>23372354</PMID>
  </reference>
  <reference>
    <citation>Chong VH, Jalihal A. Heterotopic gastric mucosal patch of the esophagus is associated with higher prevalence of laryngopharyngeal reflux symptoms. Eur Arch Otorhinolaryngol. 2010 Nov;267(11):1793-9. doi: 10.1007/s00405-010-1259-2. Epub 2010 May 1.</citation>
    <PMID>20437050</PMID>
  </reference>
  <reference>
    <citation>Al-Mammari S, Selvarajah U, East JE, Bailey AA, Braden B. Narrow band imaging facilitates detection of inlet patches in the cervical oesophagus. Dig Liver Dis. 2014 Aug;46(8):716-9. doi: 10.1016/j.dld.2014.05.001. Epub 2014 Jun 2.</citation>
    <PMID>24890619</PMID>
  </reference>
  <reference>
    <citation>Cheng CL, Lin CH, Liu NJ, Tang JH, Kuo YL, Tsui YN. Endoscopic diagnosis of cervical esophageal heterotopic gastric mucosa with conventional and narrow-band images. World J Gastroenterol. 2014 Jan 7;20(1):242-9. doi: 10.3748/wjg.v20.i1.242.</citation>
    <PMID>24415878</PMID>
  </reference>
  <reference>
    <citation>Chung CS, Lin CK, Liang CC, Hsu WF, Lee TH. Intentional examination of esophagus by narrow-band imaging endoscopy increases detection rate of cervical inlet patch. Dis Esophagus. 2015 Oct;28(7):666-72. doi: 10.1111/dote.12252. Epub 2014 Jul 24.</citation>
    <PMID>25059461</PMID>
  </reference>
  <reference>
    <citation>Vesper I, Schmiegel W, Brechmann T. Equal detection rate of cervical heterotopic gastric mucosa in standard white light, high definition and narrow band imaging endoscopy. Z Gastroenterol. 2015 Nov;53(11):1247-54. doi: 10.1055/s-0041-104226. Epub 2015 Nov 12.</citation>
    <PMID>26562398</PMID>
  </reference>
  <reference>
    <citation>Azar C, Jamali F, Tamim H, Abdul-Baki H, Soweid A. Prevalence of endoscopically identified heterotopic gastric mucosa in the proximal esophagus: endoscopist dependent? J Clin Gastroenterol. 2007 May-Jun;41(5):468-71. doi: 10.1097/01.mcg.0000225519.59030.8d.</citation>
    <PMID>17450028</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>H-T. Centrum Medyczne Sp. z o.o. sp. k</investigator_affiliation>
    <investigator_full_name>Tomasz Romańczyk</investigator_full_name>
    <investigator_title>Principal Investigator Tomasz Romańczyk MD, PhD</investigator_title>
  </responsible_party>
  <keyword>heterotopic gastric mucosa</keyword>
  <keyword>cervical inlet patch</keyword>
  <keyword>narrow band imaging</keyword>
  <keyword>endoscopy</keyword>
  <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/NCT03015571
org study id: HT-001
nct id: NCT03015571
lead sponsor: 
has dmc: No
The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely
      used during esophagus inspection at diagnostic gastroscopy.
Heterotopic gastric mucosa, also called inlet patch, is area of ectopic gastric mucosa with
      common location at proximal part of esophagus. Because of the location, lesions are likely to
      be missed during routine gastroscopy. The clinical significance of inlet patches remains
      unknown, however they may be symptomatic and may cause morphologic changes such as
      strictures, ulcers, webs, stenoses or even adenocarcinomas. Moreover inlet patches may be
      correlated with reflux symptoms up to 73,1%. Several studies were conducted to determine
      whether NBI improves detection of cervical inlet patches, some of them were also prospective
      studies, however no randomized study was conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Detection of heterotopic gastric mucosa in the proximal esophagus
time frame: Day 1
measure: Total and esophagus inspection time
time frame: Day 1
measure: Detection of other upper gastrointestinal lesions
time frame: Day 1
measure: Correlation of throat and esophageal reflux symptoms with cervical inlet patches
time frame: Day 1
measure: Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy
time frame: Day 1
measure: Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence
time frame: Day 1
arm group label: NBI
arm group type: Experimental
description: Use of Narrow Band Imaging with regular care of cervical inlet patches detection.
arm group label: WL
arm group type: Placebo Comparator
description: Use of High Definition White Light (WL) with regular care of cervical inlet patches detection.
arm group label: NBI increased care
arm group type: Experimental
description: Use of Narrow Band Imaging with increased care of cervical inlet patches detection.
arm group label: WL increased care
arm group type: Placebo Comparator
description: Use of High Definition White Light (WL) with increased care of cervical inlet patches detection.
intervention type: Device
intervention name: Esophagus inspection in Narrow Band imaging.
description: During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection.
arm group label: NBI
intervention type: Device
intervention name: Standard High definition endoscopy.
description: Whole procedure will be performed in standard High definition endoscopy.
arm group label: WL
intervention type: Device
intervention name: Esophagus inspection in Narrow Band imaging and increased care.
description: During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection and with increased care of cervical inlet patches detection.
arm group label: NBI increased care
intervention type: Device
intervention name: Standard High definition endoscopy and increased care.
description: Whole procedure will be performed in standard High definition endoscopy with increased care of cervical inlet patches detection.
arm group label: WL increased care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
citation: von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.
PMID: 15056100
citation: Maconi G, Pace F, Vago L, Carsana L, Bargiggia S, Bianchi Porro G. Prevalence and clinical features of heterotopic gastric mucosa in the upper oesophagus (inlet patch). Eur J Gastroenterol Hepatol. 2000 Jul;12(7):745-9. doi: 10.1097/00042737-200012070-00005.
PMID: 10929900
citation: Chong VH. Clinical significance of heterotopic gastric mucosal patch of the proximal esophagus. World J Gastroenterol. 2013 Jan 21;19(3):331-8. doi: 10.3748/wjg.v19.i3.331.
PMID: 23372354
citation: Chong VH, Jalihal A. Heterotopic gastric mucosal patch of the esophagus is associated with higher prevalence of laryngopharyngeal reflux symptoms. Eur Arch Otorhinolaryngol. 2010 Nov;267(11):1793-9. doi: 10.1007/s00405-010-1259-2. Epub 2010 May 1.
PMID: 20437050
citation: Al-Mammari S, Selvarajah U, East JE, Bailey AA, Braden B. Narrow band imaging facilitates detection of inlet patches in the cervical oesophagus. Dig Liver Dis. 2014 Aug;46(8):716-9. doi: 10.1016/j.dld.2014.05.001. Epub 2014 Jun 2.
PMID: 24890619
citation: Cheng CL, Lin CH, Liu NJ, Tang JH, Kuo YL, Tsui YN. Endoscopic diagnosis of cervical esophageal heterotopic gastric mucosa with conventional and narrow-band images. World J Gastroenterol. 2014 Jan 7;20(1):242-9. doi: 10.3748/wjg.v20.i1.242.
PMID: 24415878
citation: Chung CS, Lin CK, Liang CC, Hsu WF, Lee TH. Intentional examination of esophagus by narrow-band imaging endoscopy increases detection rate of cervical inlet patch. Dis Esophagus. 2015 Oct;28(7):666-72. doi: 10.1111/dote.12252. Epub 2014 Jul 24.
PMID: 25059461
citation: Vesper I, Schmiegel W, Brechmann T. Equal detection rate of cervical heterotopic gastric mucosa in standard white light, high definition and narrow band imaging endoscopy. Z Gastroenterol. 2015 Nov;53(11):1247-54. doi: 10.1055/s-0041-104226. Epub 2015 Nov 12.
PMID: 26562398
citation: Azar C, Jamali F, Tamim H, Abdul-Baki H, Soweid A. Prevalence of endoscopically identified heterotopic gastric mucosa in the proximal esophagus: endoscopist dependent? J Clin Gastroenterol. 2007 May-Jun;41(5):468-71. doi: 10.1097/01.mcg.0000225519.59030.8d.
PMID: 17450028
responsible party type: Sponsor-Investigator
investigator affiliation: H-T. Centrum Medyczne Sp. z o.o. sp. k
investigator full name: Tomasz Romańczyk
investigator title: Principal Investigator Tomasz Romańczyk MD, PhD
sharing ipd: No