<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/NCT02999451</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT02999451</nct_id>
  </id_info>
  <brief_title>Snare-assisted POEM for Treatment of Esophageal Achalasia</brief_title>
  <official_title>Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      POEM is a new intervention for the treatment of achalasia and has been reported to relieve&#xD;
      the dysphagia symptom effectively. Although the cost of POEM method is less than the method&#xD;
      of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the&#xD;
      patients with achalasia. In this trial, investigators plan to use snare to assist POEM&#xD;
      procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared&#xD;
      with other knifes-assisted procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success rates</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure-related adverse events</measure>
    <time_frame>baseline to 12 months after treatment</time_frame>
    <description>Adverse events are defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon (Cotton PB et al, Gastrointest Endosc 2010). Incidental findings of pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion on postoperative imaging, and subcutaneous emphysema were documented while not considered as adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>POEM procedure</time_frame>
    <description>Procedure time is measured from the start of submucosal injection until mucosal entry closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volume of intraoperative bleeding</measure>
    <time_frame>POEM procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The use of hemostatic forceps</measure>
    <time_frame>POEM procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain requiring the use of tramadol</measure>
    <time_frame>Through hospital stay after procedure, an average of 2-7 days</time_frame>
    <description>Pain related to POEM procedure requiring the use of tramadol pain medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The length of postoperative hospital stay</measure>
    <time_frame>Through hospital stay after procedure, an average of 2-7 daysc</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital costs of treatment per participants</measure>
    <time_frame>Through hospital stay after procedure, an average of 2-7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eckardt score</measure>
    <time_frame>baseline, 3 months and 12 months after treatment</time_frame>
    <description>The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manometry parameters</measure>
    <time_frame>baseline and 3 months after treatment</time_frame>
    <description>Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum esophageal diameter on barium esophagram</measure>
    <time_frame>baseline and 3 months after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastroesophageal reflux disease questionnaire (GerdQ) score</measure>
    <time_frame>baseline, 3 months and 12 months after treatment</time_frame>
    <description>The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score &gt;7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux esophagitis on post-POEM endoscopy</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Esophageal Achalasia</condition>
  <arm_group>
    <arm_group_label>snare group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>snare-assisted POEM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>knife-assisted POEM</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>snare-assisted POEM</intervention_name>
    <description>POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.&#xD;
After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.&#xD;
A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.&#xD;
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.&#xD;
The mucosal incision is closed with endoclips.</description>
    <arm_group_label>snare group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>knife-assisted POEM</intervention_name>
    <description>POEM is performed by using a conventional endoscopic knife.&#xD;
After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.&#xD;
A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.&#xD;
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.&#xD;
The mucosal incision is closed with endoclips.</description>
    <arm_group_label>conventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-70 years&#xD;
&#xD;
          -  Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper&#xD;
             endoscopy&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class &gt; Ⅲ&#xD;
&#xD;
          -  Previous endoscopic or surgical treatment for achalasia&#xD;
&#xD;
          -  Esophageal malignancy&#xD;
&#xD;
          -  Pregnant&#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>Xiangbin Xing, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Xiangbin Xing</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Peroral endoscopic myotomy</keyword>
  <keyword>Snare</keyword>
  <keyword>Endoscopic knife</keyword>
  <keyword>Esophageal Achalasia</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/NCT02999451
org study id: 123
nct id: NCT02999451
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
POEM is a new intervention for the treatment of achalasia and has been reported to relieve
      the dysphagia symptom effectively. Although the cost of POEM method is less than the method
      of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the
      patients with achalasia. In this trial, investigators plan to use snare to assist POEM
      procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared
      with other knifes-assisted procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical success rates
time frame: 12 months after treatment
description: Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
measure: Procedure-related adverse events
time frame: baseline to 12 months after treatment
description: Adverse events are defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon (Cotton PB et al, Gastrointest Endosc 2010). Incidental findings of pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion on postoperative imaging, and subcutaneous emphysema were documented while not considered as adverse events.
measure: Procedure time
time frame: POEM procedure
description: Procedure time is measured from the start of submucosal injection until mucosal entry closure.
measure: The volume of intraoperative bleeding
time frame: POEM procedure
measure: The use of hemostatic forceps
time frame: POEM procedure
measure: Postoperative pain requiring the use of tramadol
time frame: Through hospital stay after procedure, an average of 2-7 days
description: Pain related to POEM procedure requiring the use of tramadol pain medication.
measure: The length of postoperative hospital stay
time frame: Through hospital stay after procedure, an average of 2-7 daysc
measure: Total hospital costs of treatment per participants
time frame: Through hospital stay after procedure, an average of 2-7 days
measure: Eckardt score
time frame: baseline, 3 months and 12 months after treatment
description: The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
measure: Manometry parameters
time frame: baseline and 3 months after treatment
description: Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.
measure: Maximum esophageal diameter on barium esophagram
time frame: baseline and 3 months after treatment
measure: Gastroesophageal reflux disease questionnaire (GerdQ) score
time frame: baseline, 3 months and 12 months after treatment
description: The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score >7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009).
measure: Reflux esophagitis on post-POEM endoscopy
time frame: 3 months after treatment
description: The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).
arm group label: snare group
arm group type: Experimental
description: snare-assisted POEM
arm group label: conventional group
arm group type: Active Comparator
description: knife-assisted POEM
intervention type: Device
intervention name: snare-assisted POEM
description: POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.
A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.
The mucosal incision is closed with endoclips.
arm group label: snare group
intervention type: Device
intervention name: knife-assisted POEM
description: POEM is performed by using a conventional endoscopic knife.
After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.
A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.
The mucosal incision is closed with endoclips.
arm group label: conventional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiangbin Xing, MD, PhD
role: Study Director
affiliation: First Affiliated Hospital, Sun Yat-Sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Xiangbin Xing
investigator title: MD, PhD
mesh term: Esophageal Achalasia
sharing ipd: No