<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/NCT03031704</url>
  </required_header>
  <id_info>
    <org_study_id>2016-27</org_study_id>
    <nct_id>NCT03031704</nct_id>
  </id_info>
  <brief_title>French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy</brief_title>
  <acronym>MUCO-DUO</acronym>
  <official_title>French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be&#xD;
      removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this&#xD;
      technique, albeit less dangerous than surgery, is associated with complications such as&#xD;
      haemorrhages, perforations, and more relapse than that can be observed for colorectal&#xD;
      adenomas. As no prospective data have been published this French multicenter study aim to&#xD;
      analyze results of this technique under standardized and secured procedure.&#xD;
&#xD;
      All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a&#xD;
      group of clinical researcher involved in that field (&quot; GRAPHE &quot; (Groupe de Recherche et&#xD;
      d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly&#xD;
      expected among the international society of gastroenterologists who need to confirm the&#xD;
      efficacy of endoscopy and define optimal conditions for performing adenomas resection in this&#xD;
      location Primary End Point is the two years recurrence rate. Secondary End Points are&#xD;
      frequency and type of complication after standardized endoscopic mucosectomy of duodenal&#xD;
      adenomas, frequency and type of complications after a second endoscopic mucosectomy and&#xD;
      patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring&#xD;
      endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with&#xD;
      previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions,&#xD;
      familial adenomatous polyposis and use of antiplatelet agent during the five last days.&#xD;
&#xD;
      Hundred and twenty patients will be included and followed 2 years after mucosectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">January 9, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 9, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Number of recurrence after surgery</measure>
    <time_frame>2 yeras</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Duodenal Adenoma</condition>
  <arm_group>
    <arm_group_label>Endoscopic mucosectomy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic mucosectomy</intervention_name>
    <description>Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.</description>
    <arm_group_label>Endoscopic mucosectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy&#xD;
        will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic&#xD;
             mucosectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with previous endoscopic resection,&#xD;
&#xD;
          -  patients prsenting lesion involving the major papilla, sub mucosal lesions&#xD;
&#xD;
          -  patient with familial adenomatous polyposis&#xD;
&#xD;
          -  patient undergoing use of antiplatelet agent during the five last days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle DESALBRES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philippe GRANDVAL, MD/PhD</last_name>
    <email>philippe.grandval@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Grandval, MD/PhD</last_name>
      <email>philippe.grandval@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</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>Adenoma</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/NCT03031704
org study id: 2016-27
nct id: NCT03031704
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be
      removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this
      technique, albeit less dangerous than surgery, is associated with complications such as
      haemorrhages, perforations, and more relapse than that can be observed for colorectal
      adenomas. As no prospective data have been published this French multicenter study aim to
      analyze results of this technique under standardized and secured procedure.

      All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a
      group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et
      d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly
      expected among the international society of gastroenterologists who need to confirm the
      efficacy of endoscopy and define optimal conditions for performing adenomas resection in this
      location Primary End Point is the two years recurrence rate. Secondary End Points are
      frequency and type of complication after standardized endoscopic mucosectomy of duodenal
      adenomas, frequency and type of complications after a second endoscopic mucosectomy and
      patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring
      endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with
      previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions,
      familial adenomatous polyposis and use of antiplatelet agent during the five last days.

      Hundred and twenty patients will be included and followed 2 years after mucosectomy.
observational model: Case-Only
time perspective: Prospective
measure: Number of recurrence after surgery
time frame: 2 yeras
arm group label: Endoscopic mucosectomy
intervention type: Procedure
intervention name: Endoscopic mucosectomy
description: Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.
arm group label: Endoscopic mucosectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urielle DESALBRES
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Philippe GRANDVAL, MD/PhD
email: philippe.grandval@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Adenoma
sharing ipd: No