<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/NCT01692106</url>
  </required_header>
  <id_info>
    <nct_id>NCT01692106</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia</brief_title>
  <acronym>POEM</acronym>
  <official_title>A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there&#xD;
      is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline&#xD;
      pressure in the LES. The most widespread treatment for this disease and the one that has the&#xD;
      best long term results involves cutting the muscle layers of the lower esophagus and on the&#xD;
      neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal&#xD;
      wall. This is done during a surgery through the abdomen either with a big incision or more&#xD;
      recently with the keyhole technique. This surgery has various potential complications, one of&#xD;
      which being making a hole through the mucosa or not extending the cut on the muscle long&#xD;
      enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM)&#xD;
      is a new intervention that is done also under general anesthesia in the operating room;&#xD;
      however, it involves no skin incisions and all the procedure is done through a fiber optic&#xD;
      camera. It involves making a cut in the inner layer of the esophagus and then with cautery&#xD;
      cut the muscle fibers responsible of the blockage and finally closing the initial opening&#xD;
      with clips. In this study we will investigate the feasibility of this intervention both from&#xD;
      a technical aspect as well as a logistical perspective given the local operating room&#xD;
      constraints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry.&#xD;
      Equally all patients will undergo Eckardt's and grading systems of symptom severity before&#xD;
      and after the intervention. The patients will have a gastro-graffin swallow in the first day&#xD;
      after the surgery.&#xD;
&#xD;
      Procedure: Under general anesthesia upper endoscopy is performed using a standard single&#xD;
      channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the&#xD;
      level of the mid esophagus is initially performed. A small longitudinal submucosal incision&#xD;
      is created using a standard needle knife. For a sufficient entry point as well as submucosal&#xD;
      tunnel, a dilating balloon is inserted submucosally via the created incision similar to the&#xD;
      technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated&#xD;
      to allow sufficient entrance of the endoscope. The gastroscope is advanced into the&#xD;
      submucosal space and the tunnel is created via needle knife or blunt dissection as&#xD;
      appropriate. The tunnel is created distally and is stopped several centimeters beyond the&#xD;
      lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a&#xD;
      triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are&#xD;
      divided starting 4 cm above the LES extending 2 cm beyond the previously identified&#xD;
      esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal&#xD;
      entry is closed with standard endoscopic clips. Patients will receive standard postoperative&#xD;
      care for surgical myotomy, including long-term follow-up.&#xD;
&#xD;
      If for any reason the endoscopic treatment is unable to be completed or infeasible, a&#xD;
      standard laparoscopic treatment will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</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>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 of the POEM procedure in achalasia</measure>
    <time_frame>1-6 months</time_frame>
    <description>Patients will be consecutively evaluated on effectiveness of the endoluminal procedure by conducting standard diagnostics including postoperative gastrografin swallow. After 6 months standard esophagogastroduodenoscopy (EGD), high-resolution manometry and pH impedance will be done and a Quality of Life questionnaire will be filled out. Results will be compared to historical data of 40 conventional laparoscopic Heller myotomies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>1-6 months</time_frame>
    <description>post-operative complications, intra-operative outcomes as well as the Eckardt's grading systems of symptom severity and reflux grading secondary to achalasia.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Achalasia</condition>
  <arm_group>
    <arm_group_label>peroral endoscopic myotomy (POEM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure: Per Oral Endoscopic Myotomy (POEM)</intervention_name>
    <description>lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.</description>
    <arm_group_label>peroral endoscopic myotomy (POEM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for a Heller myotomy&#xD;
&#xD;
          -  No contra-indication to general anesthesia&#xD;
&#xD;
          -  Their age is ≥18 years and ≤80 years&#xD;
&#xD;
          -  Able to give written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intervention for achalasia: any of previous Heller myotomy, Botox injections,&#xD;
             endoscopic myotomy&#xD;
&#xD;
          -  Previous mediastinal surgery&#xD;
&#xD;
          -  Any anatomical esophageal anomaly that in the opinion of the investigator may render&#xD;
             the intervention more difficult, such as sigmoid esophagus on the pre-operative barium&#xD;
             swallow or hiatal hernia &gt; 2cm.&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 40&#xD;
&#xD;
          -  Any medical condition, which in the judgment of the Investigator and/or designee makes&#xD;
             the subject a poor candidate for the investigational procedure&#xD;
&#xD;
          -  Pregnant or lactating female (Women of child bearing potential must take a pregnancy&#xD;
             test prior to surgery)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Josephs' Healthcare Hamilton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Dennis Hong MD</investigator_full_name>
    <investigator_title>Dr. Dennis Hong, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Heller myotomy</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/NCT01692106
nct id: NCT01692106
lead sponsor: 
has dmc: No
This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there
      is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline
      pressure in the LES. The most widespread treatment for this disease and the one that has the
      best long term results involves cutting the muscle layers of the lower esophagus and on the
      neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal
      wall. This is done during a surgery through the abdomen either with a big incision or more
      recently with the keyhole technique. This surgery has various potential complications, one of
      which being making a hole through the mucosa or not extending the cut on the muscle long
      enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM)
      is a new intervention that is done also under general anesthesia in the operating room;
      however, it involves no skin incisions and all the procedure is done through a fiber optic
      camera. It involves making a cut in the inner layer of the esophagus and then with cautery
      cut the muscle fibers responsible of the blockage and finally closing the initial opening
      with clips. In this study we will investigate the feasibility of this intervention both from
      a technical aspect as well as a logistical perspective given the local operating room
      constraints.
All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry.
      Equally all patients will undergo Eckardt's and grading systems of symptom severity before
      and after the intervention. The patients will have a gastro-graffin swallow in the first day
      after the surgery.

      Procedure: Under general anesthesia upper endoscopy is performed using a standard single
      channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the
      level of the mid esophagus is initially performed. A small longitudinal submucosal incision
      is created using a standard needle knife. For a sufficient entry point as well as submucosal
      tunnel, a dilating balloon is inserted submucosally via the created incision similar to the
      technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated
      to allow sufficient entrance of the endoscope. The gastroscope is advanced into the
      submucosal space and the tunnel is created via needle knife or blunt dissection as
      appropriate. The tunnel is created distally and is stopped several centimeters beyond the
      lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a
      triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are
      divided starting 4 cm above the LES extending 2 cm beyond the previously identified
      esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal
      entry is closed with standard endoscopic clips. Patients will receive standard postoperative
      care for surgical myotomy, including long-term follow-up.

      If for any reason the endoscopic treatment is unable to be completed or infeasible, a
      standard laparoscopic treatment will be performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: feasibility of the POEM procedure in achalasia
time frame: 1-6 months
description: Patients will be consecutively evaluated on effectiveness of the endoluminal procedure by conducting standard diagnostics including postoperative gastrografin swallow. After 6 months standard esophagogastroduodenoscopy (EGD), high-resolution manometry and pH impedance will be done and a Quality of Life questionnaire will be filled out. Results will be compared to historical data of 40 conventional laparoscopic Heller myotomies.
measure: complications
time frame: 1-6 months
description: post-operative complications, intra-operative outcomes as well as the Eckardt's grading systems of symptom severity and reflux grading secondary to achalasia.
arm group label: peroral endoscopic myotomy (POEM)
arm group type: Experimental
description: The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study.
intervention type: Procedure
intervention name: Procedure: Per Oral Endoscopic Myotomy (POEM)
description: lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.
arm group label: peroral endoscopic myotomy (POEM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dennis Hong, MD
role: Principal Investigator
affiliation: St. Josephs' Healthcare Hamilton
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Dennis Hong MD
investigator title: Dr. Dennis Hong, Principal Investigator
mesh term: Esophageal Achalasia