<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/NCT03278327</url>
  </required_header>
  <id_info>
    <org_study_id>B-ARMS-IPC 2016-017</org_study_id>
    <nct_id>NCT03278327</nct_id>
  </id_info>
  <brief_title>Impact of an Endoscopic Treatment of the Line Z on the Gastronomic Recurrence and the Gastro- Esophageal Reflux Disease in the Care of the Adenocarcinoma of Barrett's Oesophagus</brief_title>
  <acronym>B-ARMS</acronym>
  <official_title>Impact of an Endoscopic Treatment of the Line Z on the Gastronomic Recurrence and the Gastro- Esophageal Reflux Disease in the Care of the Adenocarcinoma of Barrett's Oesophagus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</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>
      Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal&#xD;
      metaplasia under the effect of gastro- esophageal reflux disease (GERD).&#xD;
&#xD;
      This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then&#xD;
      invasive adenocarcinoma.&#xD;
&#xD;
      The treatment of the HGD of the Barrett is the endoscopic treatment. It is about a&#xD;
      superficial treatment of tumor without ganglionar invasion by definition.&#xD;
&#xD;
      The endoscopic treatment of the Barrett began in the 2000s, and showed its long-term&#xD;
      efficiency.&#xD;
&#xD;
      The studied factors of recurrences are the length of the Barrett, the influence of the&#xD;
      eradication completes of the Barrett besides the eradication of the dysplasia, as well as the&#xD;
      duration of spacing of the procedures. An anatomical zone is particularly delicate to treat.&#xD;
      It is about the anatomical junction between the oesophagus and the stomach appointed junction&#xD;
      oeso-gastric or cardia or line Z.&#xD;
&#xD;
      This almost virtual zone is the site of most of the recurrence. The first cause of the&#xD;
      oesophagus of Barrett and of its transformation in HGD is the reflux.&#xD;
&#xD;
      This reflux can be handled by medicinal action inhibitor of the pump with proton (PPI) or by&#xD;
      surgery (hemi-fundo plicator). This reflux is probably the cause of the long-term recurrence&#xD;
      found in the literature.&#xD;
&#xD;
      The surgery is a good treatment of the reflux with however unsatisfactory long-term results.&#xD;
      On the other hand, the surgery is little used after endoscopic treatment of a HGD not to&#xD;
      compromise the surveillance and the detection of a second offense potentially masked in the&#xD;
      surgical fundo-plicator. The endoscopic treatment of the expensive ebb because of the based&#xD;
      necessary material too on a fundo-plicator is complicated with use in reason also of his&#xD;
      cost.&#xD;
&#xD;
      The medical treatment by PPI for life, besides his duration and thus the potential hardness&#xD;
      for the patient, presents long-term complications recently described.&#xD;
&#xD;
      Effects on the appearance of gastric precancerous lesion is not certain, but this association&#xD;
      with an osteoporosis is more proved true.&#xD;
&#xD;
      The PPI could also be a etiologic factor of chronic renal insufficiency and insanity.&#xD;
&#xD;
      An endoscopic treatment describes by Inoue &quot; Anti-Reflux Mucosectomy &quot; ( ARMS) allows to&#xD;
      decrease the gastro- esophageal reflux disease.&#xD;
&#xD;
      This treatment is an equivalent of on treatment of the line Z which would at the same time&#xD;
      allow to make sure of the decrease of recurrence on the line Z by complete treatment of this&#xD;
      one and to handle the reflux of these patients.&#xD;
&#xD;
      In this experimental series, 10 patients having made this endoscopic treatment were able to&#xD;
      stop their treatment by PPI.&#xD;
&#xD;
      The purpose of this study will be to make sure of the efficiency of the endoscopic treatment&#xD;
      of the reflux by it on treatment of this line Z while decreasing the frequent recurrences on&#xD;
      this line Z.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suggest that there are significantly more than 60 % of patients with a relative decrease of at least 50 % between the total percentages of esophageal time crossed in pH4 (Ph metric dosage) before and after endoscopic treatment.</measure>
    <time_frame>36 months</time_frame>
    <description>Realization of Ph metric dosage (Gastric Ph monitoring)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.</measure>
    <time_frame>12 months.</time_frame>
    <description>Realization of several follow-up at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.</measure>
    <time_frame>24 months.</time_frame>
    <description>Realization of several follow-up at 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up at 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the score of DeMeester of the reflux before and after endoscopic treatment</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the clinical signs of the reflux before and after endoscopic treatment</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidences accumulated of recurrence</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of endoscopic complications</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Inhibitor of the pump with proton (PPI)</measure>
    <time_frame>36 months.</time_frame>
    <description>Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Barrett Esophagus Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Endoscopic resection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.</intervention_name>
    <description>Endoscopic resection treatment</description>
    <arm_group_label>Endoscopic resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic resection at month 2 and month 4</intervention_name>
    <description>System of endoscopic resection of the mucous hurts which can take several forms according to the technical necessities.&#xD;
The device the most used in this case is the system COOK Medical Duett of Laboratories.&#xD;
The duration of the treatment will be the same duration as the classic endoscopic resection, that is 30 in 60 minutes.&#xD;
The resection will be preceded by injection of physiological salt solution tinged with carmine indigo in the sub-mucous membrane.</description>
    <arm_group_label>Endoscopic resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 75 years,&#xD;
&#xD;
          -  High grade dysplasia or superficial Barrett's oesophagus adenocarcinoma diagnosis,&#xD;
&#xD;
          -  Written informed consent,&#xD;
&#xD;
          -  Affiliation to Social Security System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hiatal hernia,&#xD;
&#xD;
          -  Surgical histories treatment of gastro- esophageal reflux disease,&#xD;
&#xD;
          -  Woman pregnant or susceptible to the being,&#xD;
&#xD;
          -  Patients deprived of liberty or placed Under the authority of a tutor,&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol or follow-up schedule,&#xD;
&#xD;
          -  Contraindications to the endoscopic procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CAILLOL Fabrice, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GENRE Dominique, MD</last_name>
    <phone>33 (0) 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>COURNIER Sandra</last_name>
    <phone>33 (0) 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GENRE</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>COURNIER Sandra</last_name>
      <phone>33 (0) 4 91 22 37 78</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>CAILLOL Fabrice, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.institutpaolicalmettes.fr</url>
    <description>Institut PAOLI-CALMETTES</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</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>Adenocarcinoma</mesh_term>
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Recurrence</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/NCT03278327
org study id: B-ARMS-IPC 2016-017
nct id: NCT03278327
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal
      metaplasia under the effect of gastro- esophageal reflux disease (GERD).

      This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then
      invasive adenocarcinoma.

      The treatment of the HGD of the Barrett is the endoscopic treatment. It is about a
      superficial treatment of tumor without ganglionar invasion by definition.

      The endoscopic treatment of the Barrett began in the 2000s, and showed its long-term
      efficiency.

      The studied factors of recurrences are the length of the Barrett, the influence of the
      eradication completes of the Barrett besides the eradication of the dysplasia, as well as the
      duration of spacing of the procedures. An anatomical zone is particularly delicate to treat.
      It is about the anatomical junction between the oesophagus and the stomach appointed junction
      oeso-gastric or cardia or line Z.

      This almost virtual zone is the site of most of the recurrence. The first cause of the
      oesophagus of Barrett and of its transformation in HGD is the reflux.

      This reflux can be handled by medicinal action inhibitor of the pump with proton (PPI) or by
      surgery (hemi-fundo plicator). This reflux is probably the cause of the long-term recurrence
      found in the literature.

      The surgery is a good treatment of the reflux with however unsatisfactory long-term results.
      On the other hand, the surgery is little used after endoscopic treatment of a HGD not to
      compromise the surveillance and the detection of a second offense potentially masked in the
      surgical fundo-plicator. The endoscopic treatment of the expensive ebb because of the based
      necessary material too on a fundo-plicator is complicated with use in reason also of his
      cost.

      The medical treatment by PPI for life, besides his duration and thus the potential hardness
      for the patient, presents long-term complications recently described.

      Effects on the appearance of gastric precancerous lesion is not certain, but this association
      with an osteoporosis is more proved true.

      The PPI could also be a etiologic factor of chronic renal insufficiency and insanity.

      An endoscopic treatment describes by Inoue " Anti-Reflux Mucosectomy " ( ARMS) allows to
      decrease the gastro- esophageal reflux disease.

      This treatment is an equivalent of on treatment of the line Z which would at the same time
      allow to make sure of the decrease of recurrence on the line Z by complete treatment of this
      one and to handle the reflux of these patients.

      In this experimental series, 10 patients having made this endoscopic treatment were able to
      stop their treatment by PPI.

      The purpose of this study will be to make sure of the efficiency of the endoscopic treatment
      of the reflux by it on treatment of this line Z while decreasing the frequent recurrences on
      this line Z.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Suggest that there are significantly more than 60 % of patients with a relative decrease of at least 50 % between the total percentages of esophageal time crossed in pH4 (Ph metric dosage) before and after endoscopic treatment.
time frame: 36 months
description: Realization of Ph metric dosage (Gastric Ph monitoring)
measure: Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
time frame: 12 months.
description: Realization of several follow-up at 12 months.
measure: Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
time frame: 24 months.
description: Realization of several follow-up at 24 months.
measure: Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
time frame: 36 months.
description: Realization of several follow-up at 36 months.
measure: Evolution of the score of DeMeester of the reflux before and after endoscopic treatment
time frame: 36 months.
description: Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
measure: Evolution of the clinical signs of the reflux before and after endoscopic treatment
time frame: 36 months.
description: Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
measure: Incidences accumulated of recurrence
time frame: 36 months.
description: Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
measure: Rate of endoscopic complications
time frame: 36 months.
description: Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
measure: Use of Inhibitor of the pump with proton (PPI)
time frame: 36 months.
description: Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
arm group label: Endoscopic resection
arm group type: Other
intervention type: Procedure
intervention name: Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.
description: Endoscopic resection treatment
arm group label: Endoscopic resection
intervention type: Device
intervention name: Endoscopic resection at month 2 and month 4
description: System of endoscopic resection of the mucous hurts which can take several forms according to the technical necessities.
The device the most used in this case is the system COOK Medical Duett of Laboratories.
The duration of the treatment will be the same duration as the classic endoscopic resection, that is 30 in 60 minutes.
The resection will be preceded by injection of physiological salt solution tinged with carmine indigo in the sub-mucous membrane.
arm group label: Endoscopic resection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: CAILLOL Fabrice, MD
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: GENRE Dominique, MD
phone: 33 (0) 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
last name: COURNIER Sandra
phone: 33 (0) 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
url: http://www.institutpaolicalmettes.fr
description: Institut PAOLI-CALMETTES
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Barrett Esophagus
mesh term: Gastroesophageal Reflux
mesh term: Recurrence
sharing ipd: No