<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/NCT04446208</url>
  </required_header>
  <id_info>
    <org_study_id>SFED N 146</org_study_id>
    <nct_id>NCT04446208</nct_id>
  </id_info>
  <brief_title>Endoscopy for Post-operative Fistula</brief_title>
  <acronym>FISTULENDO</acronym>
  <official_title>Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aymeric Becq</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Society of Digestive Endoscopy</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>
      Endoscopic treatment of early post-operative fistula in patients with underlying esophageal&#xD;
      or gastric cancer has now become the standard of care. However, data regarding the yield of&#xD;
      this type of treatment is lacking. This study aims to evaluate endoscopic management of this&#xD;
      post-operative complication. The main outcome of this prospective observational study&#xD;
      conducted in tertiary centers in France is fistula healing defined as the absence of&#xD;
      collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of&#xD;
      the endoscopic treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fistula healing</measure>
    <time_frame>3 months after the end of the endoscopic</time_frame>
    <description>The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Post-operative Fistula</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopy</intervention_name>
    <description>Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (&lt; 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with post-operative fistula of the upper digestive tract, in the setting of a&#xD;
        cancerous underlying condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years&#xD;
&#xD;
          -  Early fistula (&lt; 30 days)&#xD;
&#xD;
          -  Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy&#xD;
&#xD;
          -  Indication of endoscopic management: metal stents and/or plastic stents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Incapable of decision making and informed consent&#xD;
&#xD;
          -  Life expectancy &lt; 1 month&#xD;
&#xD;
          -  General anesthesia contra-indication&#xD;
&#xD;
          -  Late fistula (&gt; 30 days)&#xD;
&#xD;
          -  Prior endoscopic treatment&#xD;
&#xD;
          -  Wall ischemia&#xD;
&#xD;
          -  Duodenum or small bowel fistula&#xD;
&#xD;
          -  Post bariatric surgery&#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>Saint Antoine Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aymeric Becq, MD</last_name>
      <phone>0664233441</phone>
      <phone_ext>33</phone_ext>
      <email>aymeric.becq@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>French Society of Digestive Endoscopy</investigator_affiliation>
    <investigator_full_name>Aymeric Becq</investigator_full_name>
    <investigator_title>Medical doctor-principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fistula</keyword>
  <keyword>Upper digestive tract</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fistula</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/NCT04446208
org study id: SFED N 146
nct id: NCT04446208
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic treatment of early post-operative fistula in patients with underlying esophageal
      or gastric cancer has now become the standard of care. However, data regarding the yield of
      this type of treatment is lacking. This study aims to evaluate endoscopic management of this
      post-operative complication. The main outcome of this prospective observational study
      conducted in tertiary centers in France is fistula healing defined as the absence of
      collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of
      the endoscopic treatment.
observational model: Cohort
time perspective: Prospective
measure: fistula healing
time frame: 3 months after the end of the endoscopic
description: The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.
intervention type: Procedure
intervention name: Endoscopy
description: Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: French Society of Digestive Endoscopy
investigator full name: Aymeric Becq
investigator title: Medical doctor-principal Investigator
mesh term: Fistula