<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/NCT03306485</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0427</org_study_id>
    <nct_id>NCT03306485</nct_id>
  </id_info>
  <brief_title>Post Prandial High Resolution Impedance- Manometry</brief_title>
  <official_title>Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</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>
      Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) -&#xD;
      suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat).&#xD;
      Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of&#xD;
      patients have persistent symptoms on proton pump inhibitor. Complementary examinations are&#xD;
      then required to determine the cause of persistent symptoms (non compliance to treatment,&#xD;
      persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux&#xD;
      hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect&#xD;
      reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal&#xD;
      pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to&#xD;
      determine gastro-esophageal reflux disease mechanisms especially when performed post&#xD;
      prandially. Further some publications demonstrated that the number of reflux episodes&#xD;
      detected during the post prandial period might be well correlated to the total number of&#xD;
      reflux episodes recorded during 24 h.&#xD;
&#xD;
      The hypothesis of this study is that 1-hour post prandial esophageal High Resolution&#xD;
      Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can&#xD;
      replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to&#xD;
      compare the number of reflux episodes detected with esophageal High Resolution&#xD;
      Impedance-Manometry performed during 1-h post prandial period to the total number of reflux&#xD;
      episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">February 27, 2023</completion_date>
  <primary_completion_date type="Actual">February 27, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>High Resolution Impedance Manometry</measure>
    <time_frame>1 hour</time_frame>
    <description>Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-h pH-impedance</measure>
    <time_frame>24 hour</time_frame>
    <description>Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Gastro-esophageal Reflux</condition>
  <arm_group>
    <arm_group_label>Patients with GERD symptoms refractory to PPI therapy</arm_group_label>
    <description>Patients with proven GERD (gastro-esophageal reflux disease) off PPI (proton pump inhibitor) (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure &gt; 5% on pH monitoring performed off PPI).&#xD;
These patients have persistent heartburn and/or regurgitation despite double dose proton pump inhibitor. Patients are referred for esophageal high resolution impedance manometry and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI</intervention_name>
    <description>Esophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter.</description>
    <arm_group_label>Patients with GERD symptoms refractory to PPI therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Gastro-esophageal reflux disease symptoms refractory to proton pump inhibitor&#xD;
        therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of both gender older than 18 years&#xD;
&#xD;
          -  Patient referred for post prandial esophageal high resolution manometry combined with&#xD;
             impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor&#xD;
&#xD;
          -  Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy&#xD;
&#xD;
          -  Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade&#xD;
             B, C or D esophagitis and/or esophageal acid exposure &gt; 5% on esophageal pH monitoring&#xD;
             off proton pump inhibitor)&#xD;
&#xD;
          -  Absence of major esophageal motility disorders (achalasia, esophago-gastric junction&#xD;
             outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)&#xD;
&#xD;
          -  Patient who does not decline to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient younger than 18 years&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller&#xD;
             myotomy, bariatric surgery)&#xD;
&#xD;
          -  Patient with severe renal insufficiency&#xD;
&#xD;
          -  Patient with severe cardiac insufficiency&#xD;
&#xD;
          -  Patient legally incompetent or unable to give consent&#xD;
&#xD;
          -  Patient who declines to participate to the study&#xD;
&#xD;
          -  Participation to another study at the same time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</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/NCT03306485
org study id: 69HCL17_0427
nct id: NCT03306485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) -
      suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat).
      Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of
      patients have persistent symptoms on proton pump inhibitor. Complementary examinations are
      then required to determine the cause of persistent symptoms (non compliance to treatment,
      persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux
      hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect
      reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal
      pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to
      determine gastro-esophageal reflux disease mechanisms especially when performed post
      prandially. Further some publications demonstrated that the number of reflux episodes
      detected during the post prandial period might be well correlated to the total number of
      reflux episodes recorded during 24 h.

      The hypothesis of this study is that 1-hour post prandial esophageal High Resolution
      Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can
      replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to
      compare the number of reflux episodes detected with esophageal High Resolution
      Impedance-Manometry performed during 1-h post prandial period to the total number of reflux
      episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.
observational model: Other
time perspective: Prospective
measure: High Resolution Impedance Manometry
time frame: 1 hour
description: Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal
measure: 24-h pH-impedance
time frame: 24 hour
description: Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring
arm group label: Patients with GERD symptoms refractory to PPI therapy
description: Patients with proven GERD (gastro-esophageal reflux disease) off PPI (proton pump inhibitor) (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on pH monitoring performed off PPI).
These patients have persistent heartburn and/or regurgitation despite double dose proton pump inhibitor. Patients are referred for esophageal high resolution impedance manometry and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor.
intervention type: Other
intervention name: Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI
description: Esophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter.
arm group label: Patients with GERD symptoms refractory to PPI therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
sharing ipd: No