<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/NCT02259283</url>
  </required_header>
  <id_info>
    <org_study_id>POEM-ICH</org_study_id>
    <nct_id>NCT02259283</nct_id>
  </id_info>
  <brief_title>Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia</brief_title>
  <acronym>POEM</acronym>
  <official_title>Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently&#xD;
      the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo&#xD;
      myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is&#xD;
      performed, and has advantage over surgery because it is performed endoscopically, thus is&#xD;
      less invasive. One potential disadvantage in respect to surgery may be that it may determine&#xD;
      higher rates of post-operative reflux. The purpose of this study is to prospectively assess&#xD;
      the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3&#xD;
      and 12 months.&#xD;
&#xD;
      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of&#xD;
      achalasia, without megaesophagus or colonic esophagus, will be included for the POEM&#xD;
      procedure.&#xD;
&#xD;
      This study will last about 2 years. The aim is the feasibility, security and success rate of&#xD;
      POEM for achalasia. Patients will be followed for at least one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</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>Feasibility</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of patients with successful POEM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>24 months</time_frame>
    <description>A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>24 months</time_frame>
    <description>Quality of life as measured by questionnaires (SF36 and l'EORTC QLQ-OES24) that will be administered to the patients at 3 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux disease</measure>
    <time_frame>24 months</time_frame>
    <description>Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>24 months</time_frame>
    <description>Percentages of patients in which other interventions for dysphagia are required after the first POEM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>24 months</time_frame>
    <description>Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Achalasia</condition>
  <arm_group>
    <arm_group_label>Achalasia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hybrid Knife</intervention_name>
    <description>POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.</description>
    <arm_group_label>Achalasia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 75 years&#xD;
&#xD;
          -  Manometric diagnosis of achalasia&#xD;
&#xD;
          -  Eckardt score more than 3&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Increased surgical risk for important comorbidities,&#xD;
&#xD;
          -  Pseudoachalasia&#xD;
&#xD;
          -  Mega-esophagus (more than 7 cm) and or sigmoid esophagus,&#xD;
&#xD;
          -  Previous esophageal or gastric surgery (with the exception of gastric perforation)&#xD;
&#xD;
          -  Inability of completing the questionnarie&#xD;
&#xD;
          -  Inability to keep a commitment for follow-up&#xD;
&#xD;
          -  Esophageal diverticulum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoscopy Unit, Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.</citation>
    <PMID>1451966</PMID>
  </reference>
  <reference>
    <citation>Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.</citation>
    <PMID>20354937</PMID>
  </reference>
  <reference>
    <citation>Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.</citation>
    <PMID>22982946</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>Chief of Clinical research Project</investigator_title>
  </responsible_party>
  <keyword>achalasia</keyword>
  <keyword>per oral endoscopic myotoymy</keyword>
  <keyword>endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Achalasia</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/NCT02259283
org study id: POEM-ICH
nct id: NCT02259283
lead sponsor: 
has dmc: Yes
Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently
      the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo
      myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is
      performed, and has advantage over surgery because it is performed endoscopically, thus is
      less invasive. One potential disadvantage in respect to surgery may be that it may determine
      higher rates of post-operative reflux. The purpose of this study is to prospectively assess
      the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3
      and 12 months.

      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of
      achalasia, without megaesophagus or colonic esophagus, will be included for the POEM
      procedure.

      This study will last about 2 years. The aim is the feasibility, security and success rate of
      POEM for achalasia. Patients will be followed for at least one year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility
time frame: 24 months
description: Percentage of patients with successful POEM
measure: Clinical Success
time frame: 24 months
description: A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.
measure: Quality of Life
time frame: 24 months
description: Quality of life as measured by questionnaires (SF36 and l'EORTC QLQ-OES24) that will be administered to the patients at 3 and 12 months.
measure: Adverse events
time frame: 24 months
description: Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)
measure: Reflux disease
time frame: 24 months
description: Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry
measure: Treatment failure
time frame: 24 months
description: Percentages of patients in which other interventions for dysphagia are required after the first POEM.
measure: Efficacy
time frame: 24 months
description: Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.
arm group label: Achalasia
arm group type: Experimental
description: Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.
intervention type: Device
intervention name: Hybrid Knife
description: POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
arm group label: Achalasia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
facility: 
country: Italy
citation: Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.
PMID: 1451966
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
PMID: 20354937
citation: Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.
PMID: 22982946
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: Chief of Clinical research Project
mesh term: Esophageal Achalasia