<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/NCT02254889</url>
  </required_header>
  <id_info>
    <org_study_id>3-2011-0007</org_study_id>
    <nct_id>NCT02254889</nct_id>
  </id_info>
  <brief_title>Pain After Endoscopic Submucosal Dissection</brief_title>
  <official_title>Pain After Endoscopic Submucosal Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric&#xD;
      neoplasms. Although ESD-related complications such as bleeding and perforation have been&#xD;
      reported, data is currently lacking on the development of pain, which is one of the most&#xD;
      common adverse events after ESD. Therefore, in the present study, we investigated the&#xD;
      incidence and clinicopathologic risk factors of pain after ESD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled study was conducted evaluating 156 patients with gastric&#xD;
      neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014.&#xD;
      All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI)&#xD;
      either before or after ESD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A 10-cm VAS was used to evaluate pain after ESD.</measure>
    <time_frame>Pain was rated at 24 hours after ESD.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Gastric Neoplasm</condition>
  <arm_group>
    <arm_group_label>pre-ESD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>post-ESD group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>proton pump inhibitor</intervention_name>
    <description>). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.</description>
    <arm_group_label>post-ESD group</arm_group_label>
    <arm_group_label>pre-ESD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing ESD for gastric neoplasms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) history of acid suppressive medication within 1 week prior to the procedure; (2)&#xD;
             known gastrointestinal disorders, such as peptic ulcer disease, which might impact&#xD;
             epigastric pain assessment; (3) current or regular use of pain medication; (4) history&#xD;
             of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation&#xD;
             during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or&#xD;
             psychological disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Hoon Youn, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Da Hyun Jung</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>February 11, 2016</last_update_submitted>
  <last_update_submitted_qc>February 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Da Hyun Jung</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proton Pump Inhibitors</mesh_term>
  </intervention_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/NCT02254889
org study id: 3-2011-0007
nct id: NCT02254889
lead sponsor: 
has dmc: Yes
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric
      neoplasms. Although ESD-related complications such as bleeding and perforation have been
      reported, data is currently lacking on the development of pain, which is one of the most
      common adverse events after ESD. Therefore, in the present study, we investigated the
      incidence and clinicopathologic risk factors of pain after ESD.
A prospective randomized controlled study was conducted evaluating 156 patients with gastric
      neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014.
      All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI)
      either before or after ESD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: A 10-cm VAS was used to evaluate pain after ESD.
time frame: Pain was rated at 24 hours after ESD.
arm group label: pre-ESD group
arm group type: Active Comparator
description: All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
arm group label: post-ESD group
arm group type: Placebo Comparator
description: All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
intervention type: Drug
intervention name: proton pump inhibitor
description: ). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.
arm group label: post-ESD group
arm group label: pre-ESD group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Young Hoon Youn, MD, PhD
role: Study Director
affiliation: Gangnam Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Da Hyun Jung
investigator title: Doctor
mesh term: Stomach Neoplasms
mesh term: Proton Pump Inhibitors