<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/NCT02989883</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0999</org_study_id>
    <nct_id>NCT02989883</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Peroral Endoscopic Myotomy</brief_title>
  <official_title>Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Esophageal outflow obstruction is characterized by failure to relax the lower esophageal&#xD;
      sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent&#xD;
      stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight&#xD;
      loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the&#xD;
      LES and reduce its pressure to allow esophageal emptying. Therapeutic options include&#xD;
      pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical&#xD;
      myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has&#xD;
      recently been introduced as a minimally invasive treatment, but there have a few studies&#xD;
      regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM&#xD;
      for esophageal outflow obstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients with Eckardt score &lt;3 after the procedure</measure>
    <time_frame>1 month after the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events which are related to the procedure</measure>
    <time_frame>within 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Achalasia</condition>
  <arm_group>
    <arm_group_label>Peroral endoscopic myotomy (POEM)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who received POEM</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>peroral endoscopic myotomy</intervention_name>
    <description>The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.</description>
    <arm_group_label>Peroral endoscopic myotomy (POEM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were diagnosed as esophageal outflow obstruction&#xD;
&#xD;
          -  Patients with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnostic uncertainty&#xD;
&#xD;
          -  Patients who are not suitable for general anesthesia&#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_official>
    <last_name>Hwoon-Yong Jung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hwoon-Yong Jung</last_name>
    <email>hyjung@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hwoon-Yong Jung, M.D., PhD.</last_name>
      <email>hyjung@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Hwoon-Yong Jung, M.D., PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Do Hoon Kim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kee Don Choi, M.D., PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ji Yong Ahn, M.D., PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eun Jeong Gong, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Hwoon-Yong Jung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>achalasia</keyword>
  <keyword>POEM</keyword>
  <keyword>outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Achalasia</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/NCT02989883
org study id: 2016-0999
nct id: NCT02989883
lead sponsor: 
has dmc: Yes
Esophageal outflow obstruction is characterized by failure to relax the lower esophageal
      sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent
      stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight
      loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the
      LES and reduce its pressure to allow esophageal emptying. Therapeutic options include
      pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical
      myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has
      recently been introduced as a minimally invasive treatment, but there have a few studies
      regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM
      for esophageal outflow obstruction.
Prospective study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of patients with Eckardt score <3 after the procedure
time frame: 1 month after the procedure
measure: adverse events which are related to the procedure
time frame: within 30 days
arm group label: Peroral endoscopic myotomy (POEM)
arm group type: Other
description: Patients who received POEM
intervention type: Other
intervention name: peroral endoscopic myotomy
description: The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.
arm group label: Peroral endoscopic myotomy (POEM)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hwoon-Yong Jung
role: Principal Investigator
affiliation: Asan Medical Center
last name: Hwoon-Yong Jung
email: hyjung@amc.seoul.kr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Hwoon-Yong Jung
investigator title: Professor
mesh term: Esophageal Achalasia
sharing ipd: No