<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/NCT02977650</url>
  </required_header>
  <id_info>
    <org_study_id>016-0040</org_study_id>
    <nct_id>NCT02977650</nct_id>
  </id_info>
  <brief_title>EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge</brief_title>
  <official_title>EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hokkaido Pancreatobiliary Endoscopic Intervention Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hokkaido Pancreatobiliary Endoscopic Intervention Study Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin&#xD;
      bridge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>The rate of bleeding adverse events</measure>
    <time_frame>Within 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of thromboembolic events</measure>
    <time_frame>Within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of other adverse events</measure>
    <time_frame>Within 2 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Endoscopic Ultrasonography-guided Fine Needle Aspiration</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic ultrasonography-guided fine needle aspiration</intervention_name>
    <other_name>EUS-FNA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients taking anticoagulants who underwent EUS-FNA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Taking anticoagulants&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Platelets count less than 50000/μl&#xD;
&#xD;
          -  PT-INR more than 2.6&#xD;
&#xD;
          -  ASA more than 3&#xD;
&#xD;
          -  Severe bleeding tendency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kazumichi Kawakubo, Ph.D.</last_name>
    <phone>117161161</phone>
    <email>kkawakubo-gi@umin.ac.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <zip>0608638</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kazumichi Kawakubo</last_name>
      <phone>117161161</phone>
      <email>kkawakubo-gi@umin.ac.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hokkaido Pancreatobiliary Endoscopic Intervention Study Group</investigator_affiliation>
    <investigator_full_name>Kazumichi Kawakubo</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02977650
org study id: 016-0040
nct id: NCT02977650
lead sponsor: 
has dmc: No
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin
      bridge.
observational model: Cohort
time perspective: Prospective
measure: The rate of bleeding adverse events
time frame: Within 2 weeks
measure: The rate of thromboembolic events
time frame: Within 2 weeks
measure: The rate of other adverse events
time frame: Within 2 weeks
intervention type: Procedure
intervention name: Endoscopic ultrasonography-guided fine needle aspiration
other name: EUS-FNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kazumichi Kawakubo, Ph.D.
phone: 117161161
email: kkawakubo-gi@umin.ac.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
investigator full name: Kazumichi Kawakubo
investigator title: M.D., Ph.D.
sharing ipd: Undecided