<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/NCT03749941</url>
  </required_header>
  <id_info>
    <org_study_id>2018-SPN-GRAPHE</org_study_id>
    <nct_id>NCT03749941</nct_id>
  </id_info>
  <brief_title>Safety of EUS-FNA for Pancreatic Solid-Pseudopapillary Neoplasm (SPN) Before Surgical Resection: the SPN-GRAPHE Series</brief_title>
  <acronym>SPN-GRAPHE</acronym>
  <official_title>Safety of EUS-FNA for Pancreatic Solid-Pseudopapillary Neoplasm (SPN) Before Surgical Resection: An European Multicenter Registry-based Study on 149 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société Française d'Endoscopie Digestive</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société Française d'Endoscopie Digestive</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>
      Solid-pseudopapillary neoplasm (SPN) is a rare type of pancreatic neoplasm. A&#xD;
      cytopathological diagnosis is often mandatory before performing surgical resection.&#xD;
      Endo-ultrasonography with fine needle aspiration (EUS-FNA) improve significantly&#xD;
      pre-operative SPN diagnosis accuracy. So far, few EUS-FNA performed for SPN were published,&#xD;
      and safety of EUS-FNA for SPN has never been investigated. This retrospective European&#xD;
      multicenter case-control study compared the recurrence rate in patients with and without&#xD;
      EUS-FNA performed before primary tumor resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This European multicenter study was conducted in 22 digestive units from the GRAPHE (French&#xD;
      taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et&#xD;
      d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and&#xD;
      retrospectively included all patients who have undergone complete resection of their&#xD;
      pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of&#xD;
      cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection in&#xD;
      each center.&#xD;
&#xD;
      The data were retrospectively collected by extraction from our medical patient management&#xD;
      softwares.&#xD;
&#xD;
      The following data were collected: age, gender, symptoms, tumor size, tumor location (uncus,&#xD;
      head, isthmus, body or tail of the pancreas), presence of tumor calcifications, performing of&#xD;
      a EUS-FNA for diagnostic purposes before surgical resection, follow-up, and diagnosis of&#xD;
      recurrence of the SPN during follow-up. Other data were collected in case of EUS-FNA: path of&#xD;
      the needle puncture (transgastric or transduodenal), diameter of the needle, number of&#xD;
      passes, immediate EUS-FNA morbidity, and EUS-FNA diagnosis of SPN (certain, probable, false&#xD;
      or absent).&#xD;
&#xD;
      Patients with and without initial EUS-FNA were compared and the main criteria of this study&#xD;
      was determinate: the presence of recurrence of the SPN during follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2000</start_date>
  <completion_date type="Actual">September 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 15, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence after primary tumor resection</measure>
    <time_frame>through study completion, an average of 43 months</time_frame>
    <description>Recurrence after primary tumor resection confirmed during follow up</description>
  </primary_outcome>
  <enrollment type="Actual">149</enrollment>
  <condition>Solid Pseudopapillary Tumor</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This European multicenter study was conducted in 22 digestive units from the GRAPHE (French&#xD;
        taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et&#xD;
        d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and&#xD;
        retrospectively included all patients who have undergone complete resection of their&#xD;
        pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of&#xD;
        cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection&#xD;
        in each center.&#xD;
&#xD;
        The data were retrospectively collected by extraction from our medical patient management&#xD;
        softwares.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive patients who have undergone complete resection of their pancreatic SPN&#xD;
             were included. Inclusion criterion was the definite diagnosis of SPN on the&#xD;
             pathological examination of the complete tumor resection specimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Société Française d'Endoscopie Digestive</investigator_affiliation>
    <investigator_full_name>KARSENTI</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>EUS-FNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03749941
org study id: 2018-SPN-GRAPHE
nct id: NCT03749941
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Solid-pseudopapillary neoplasm (SPN) is a rare type of pancreatic neoplasm. A
      cytopathological diagnosis is often mandatory before performing surgical resection.
      Endo-ultrasonography with fine needle aspiration (EUS-FNA) improve significantly
      pre-operative SPN diagnosis accuracy. So far, few EUS-FNA performed for SPN were published,
      and safety of EUS-FNA for SPN has never been investigated. This retrospective European
      multicenter case-control study compared the recurrence rate in patients with and without
      EUS-FNA performed before primary tumor resection.
This European multicenter study was conducted in 22 digestive units from the GRAPHE (French
      taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et
      d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and
      retrospectively included all patients who have undergone complete resection of their
      pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of
      cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection in
      each center.

      The data were retrospectively collected by extraction from our medical patient management
      softwares.

      The following data were collected: age, gender, symptoms, tumor size, tumor location (uncus,
      head, isthmus, body or tail of the pancreas), presence of tumor calcifications, performing of
      a EUS-FNA for diagnostic purposes before surgical resection, follow-up, and diagnosis of
      recurrence of the SPN during follow-up. Other data were collected in case of EUS-FNA: path of
      the needle puncture (transgastric or transduodenal), diameter of the needle, number of
      passes, immediate EUS-FNA morbidity, and EUS-FNA diagnosis of SPN (certain, probable, false
      or absent).

      Patients with and without initial EUS-FNA were compared and the main criteria of this study
      was determinate: the presence of recurrence of the SPN during follow-up.
observational model: Cohort
time perspective: Retrospective
measure: Recurrence after primary tumor resection
time frame: through study completion, an average of 43 months
description: Recurrence after primary tumor resection confirmed during follow up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Société Française d'Endoscopie Digestive
investigator full name: KARSENTI
investigator title: principal investigator
mesh term: Neoplasms