<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/NCT04463095</url>
  </required_header>
  <id_info>
    <org_study_id>POEM EM</org_study_id>
    <nct_id>NCT04463095</nct_id>
  </id_info>
  <brief_title>Esophageal Mucosal Changes in Achalasia Cardia and Reversibility After Per Oral Endoscopic Myotomy - A Pilot Study</brief_title>
  <official_title>Esophageal Mucosal Changes in Long Standing Achalasia Cardia and Reversibility After Per Oral Endoscopic Myotomy ( POEM )</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asian Institute of Gastroenterology, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asian Institute of Gastroenterology, India</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Esophageal mucosal changes in long standing achalasia cardia and reversibility after per oral&#xD;
      endoscopic myotomy - A pilot study&#xD;
&#xD;
      Aims and Objectives:&#xD;
&#xD;
        -  To study mucosal changes in patients with achalasia cardia&#xD;
&#xD;
        -  To study potential malignant histopathological findings in long standing achalasia&#xD;
           cardia&#xD;
&#xD;
        -  To assess reversibility of mucosal changes after POEM&#xD;
&#xD;
        -  To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis&#xD;
&#xD;
        -  To study muscle biopsy by light microscopy and electron microscopy for viral inclusions&#xD;
&#xD;
      Materials and Methods:&#xD;
&#xD;
        -  Study Area - Patients of achalasia cardia undergoing POEM in Asian Institute of&#xD;
           Gastroenterology.&#xD;
&#xD;
        -  Study Design - Cross sectional study&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      •All patients of achalasia cardia who will undergo POEM and an esophageal mucosal biopsy at 3&#xD;
      months of follow up&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        -  Patients of achalasia cardia not undergoing POEM or an esophageal mucosal biopsy at 3&#xD;
           months of follow up&#xD;
&#xD;
        -  Upper gastro-intestinal surgically altered anatomy ( apart from previous Heller Myotomy&#xD;
           )&#xD;
&#xD;
        -  Pregnancy&#xD;
&#xD;
        -  Patients not giving consent for participation&#xD;
&#xD;
        -  End Point( Length of follow up )- 3 months after POEM - single follow up.&#xD;
&#xD;
      Study Procedure:&#xD;
&#xD;
      Before POEM, all patients will undergo symptom evaluation, esophagogastroduodenoscopy (EGD),&#xD;
      high resolution esophageal manometry and timed barium esophagogram.The diagnosis of achalasia&#xD;
      will be based on a combination of clinical presentation, esophagogastroduodenoscopy, barium&#xD;
      esophagogram and high resolution manometric findings.&#xD;
&#xD;
      Symptoms will be classified by using the Eckardt score.Type of Achalasia will be classified&#xD;
      according to the Chicago classification. Esophagus shape (sigmoid vs nonsigmoid), presence of&#xD;
      hiatus hernia, presence of esophagitis will be assessed on esophagogastroduodenoscopy.&#xD;
      Duration since first symptoms of achalasia will be recorded.&#xD;
&#xD;
      All patients fulfilling the inclusion criteria will undergo Per Oral Endoscopic Myotomy&#xD;
      (POEM). During POEM, a mucosal biopsy and a muscle biopsy of the Esophagus will be taken.&#xD;
      Patients will be followed up at a single time, 3 months after POEM. During the follow up&#xD;
      visit, patients will undergo esophagogastroduodenoscopy guided mucosal biopsy of the&#xD;
      Esophagus. Patients will be divided into two groups based on the duration of symptoms of&#xD;
      achalasia- Those having symptoms for 1 year or less and those having symptoms for more than 5&#xD;
      years. Histopathological changes in the Esophagus and reversibility of these changes after&#xD;
      POEM will be compared between the two study groups to draw a conclusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction and Background:&#xD;
&#xD;
      Achalasia cardiais a rare, chronic, esophageal motility disorder with an estimated annual&#xD;
      prevalence of 1 per 1,00,000 subjects. The disease can occur at all ages, but the incidence&#xD;
      seems to increase with age. The predominant symptoms are dysphagia and regurgitation, because&#xD;
      of the impaired relaxation of the lower esophageal sphincter (LES) and the loss of normal&#xD;
      peristalsis.Achalasia is a neurodegenerative disease resulting from an inflammatory and/or&#xD;
      autoimmune process ultimately leading to aganglionosis. The etiology and pathogenesis of&#xD;
      achalasia is still unknown. The primary pathophysiologic abnormality is a loss of the&#xD;
      intrinsic inhibitory innervation of the lower esophageal sphincter (LES) and the segment of&#xD;
      smooth musculature of the esophageal body. The resultant denervation and reduction of&#xD;
      post-ganglionic nerve fibers have been postulated to be related to the hypertensive or&#xD;
      non-relaxing LES in patients with achalasia.Esophagectomy or surgical myotomy specimens have&#xD;
      demonstratedabsence or reduction in ganglion cells as well as varying degrees of cytotoxic&#xD;
      T-cell inflammation in the myenteric plexus of patients with achalasia. Studies demonstrating&#xD;
      an association between achalasia and certain HLA phenotypes, and an increased immunologic&#xD;
      response to Herpes Simplex Virus-1 (HSV-1) in the serum and LES myenteric plexusof achalasia&#xD;
      patients further support the notion of inflammation playing a central role in&#xD;
      pathogenesis.However, it is not known whether this inflammation is part of the process that&#xD;
      leads to the loss of the plexus, or whether it is secondary to the outflow obstruction with&#xD;
      consecutive stasis in achalasia. Persistent esophageal distension with retention of foods and&#xD;
      fluids, bacterial overgrowth, and impaired clearance of regurgitated acid and gastric&#xD;
      contents lead to chronic inflammation and passively cause dysplasia and carcinoma. The&#xD;
      prognosis of patients who develop such carcinomas remains poor. The aim of therapy is to&#xD;
      reduce food stasis, which might interrupt the progression to carcinoma and thus reduce the&#xD;
      risk of squamous cell carcinoma.&#xD;
&#xD;
      No currently available treatment options result in regeneration of myenteric neurons to bring&#xD;
      back esophageal motility. However, lowering LES pressure can significantly reduce symptoms&#xD;
      and improve quality of life. To achieve this outcome (LES pressure reduction), therapeutic&#xD;
      techniques have been modified from time to time. Graded pneumatic balloon dilatation (PBD)&#xD;
      has replaced conventional one-time dilatation and open Heller's myotomy has cleared the way&#xD;
      for laparoscopic Heller's myotomy (LHM) with fundoplication.Recently, per oral endoscopic&#xD;
      myotomy (POEM) was introduced by Inoue et al. as a less invasive and effective curative&#xD;
      treatment option with minimal complications.Peroral endoscopic myotomy (POEM)combines&#xD;
      thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive&#xD;
      procedure.Other therapeutic options include endoscopic balloon dilatation and surgical&#xD;
      myotomy. Endoscopic balloon dilatation is still widely performed because of its relative&#xD;
      non-invasiveness and simplicity, but it has a relatively lower success rate and often&#xD;
      requires multiple treatment sessions. Surgical myotomy has been thought to be the curative&#xD;
      therapeutic choice for symptomatic achalasia. However, it requires skin incisions and&#xD;
      additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the&#xD;
      anatomical integrity of the LES and possibly minimizes postoperative reflux.&#xD;
&#xD;
      Rationale of the study:&#xD;
&#xD;
        -  There have been very few studies systematically analysing the histopathological changes&#xD;
           in the mucosa and muscle of the Esophagus in Achalasia Cardia.&#xD;
&#xD;
        -  Therefore we want to study the histopathological changes in the mucosa and muscle of the&#xD;
           Esophagus in achalasia cardia patients and observe how the histopathological changes&#xD;
           differ between early achalasia cardia and long-standing achalasia cardia.&#xD;
&#xD;
        -  Achalasia Cardia is a potential pre-malignant condition which can lead to esophageal&#xD;
           carcinoma.&#xD;
&#xD;
        -  Principal investogator want to study the pre-malignant and malignant changes in the&#xD;
           Esophagus in achalasia cardia patients.&#xD;
&#xD;
        -  Also want to study whether per oral endoscopic myotomy ( POEM ) reverses the&#xD;
           histopathological and pre-malignant changes in the Esophagus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1.To study mucosal changes in patients with achalasia cardia</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of ganglion cells will be measured in the mucosal biopsy (normal number of ganglion cells are 2 to 12 per mm on Histopathological examination). The size of the ganglion cells will be measured.(normal size of ganglion cells is 10 to 40 microns). Median number of neurons will be measured.(normal median number of neurons are 2 to 6 on histopathological examination).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2. To study potential malignant histopathological findings in long standing achalasia cardia</measure>
    <time_frame>12 weeks</time_frame>
    <description>The mean Ki-67 and mean p53 positive ratio will be measured in the histopathological examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3.To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis</measure>
    <time_frame>12 weeks</time_frame>
    <description>The fibrosis score will be measured in the histopathological examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4. To evaluate reversibility of mucosal changes after per oral endoscopic myotomy (POEM )</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of ganglion cells will be measured in the mucosal biopsy (normal number of ganglion cells are 2 to 12 per mm on Histopathological examination). The size of the ganglion cells will be measured.(normal size of ganglion cells is 10 to 40 microns). Median number of neurons will be measured.(normal median number of neurons are 2 to 6 on histopathological examination). These findings will be measured 12 weeks post POEM.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Histopathology</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PER ORAL ENDOSCOPY MYOTOMY (POEM)</intervention_name>
    <description>Peroral endoscopic myotomy (POEM)combines thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive procedure.Other therapeutic options include endoscopic balloon dilatation and surgical myotomy. Endoscopic balloon dilatation is still widely performed because of its relative non-invasiveness and simplicity, but it has a relatively lower success rate and often requires multiple treatment sessions. Surgical myotomy has been thought to be the curative therapeutic choice for symptomatic achalasia. However, it requires skin incisions and additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the anatomical integrity of the LES and possibly minimizes postoperative reflux.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Since the present study is pilot based in assessing the primary outcome, it has been&#xD;
        decided to cover 30 patients and follow up at 3 months. Hence no power calculation is used&#xD;
        to estimate the sample size.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • All patients of achalasia cardia who will undergo POEM and an esophageal mucosal&#xD;
             biopsy at 3 months of follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients of achalasia cardia not undergoing POEM or an esophageal mucosal biopsy at&#xD;
             3 months of follow up&#xD;
&#xD;
               -  Upper gastro-intestinal surgically altered anatomy ( apart from previous Heller&#xD;
                  Myotomy )&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Patients not giving consent for participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Pranav Milind Ambardekar, MBBS MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian institute of Gastroenterology/AIG Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr Pranav Milind Ambardekar, MBBS MD</last_name>
    <phone>04023378888</phone>
    <email>pranavambardekar@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mr Rajesh Goud Maragoni, MPharma, MBA</last_name>
    <phone>04023378888</phone>
    <email>rajeshgoud761@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asian institute of Gastroenterology/AIG Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Pranav Milind Ambardekar, MBBS MD</last_name>
      <phone>04023378888</phone>
      <email>pranavambardekar@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rajesh Goud Maragoni, Mpharma,MBA</last_name>
      <phone>04023378888</phone>
      <phone_ext>802</phone_ext>
      <email>rajeshgoud761@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Dr Pranav Milind Ambardekar, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asian Institute of Gastroenterology, India</investigator_affiliation>
    <investigator_full_name>Mohan Ramchandani</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <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/NCT04463095
org study id: POEM EM
nct id: NCT04463095
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Esophageal mucosal changes in long standing achalasia cardia and reversibility after per oral
      endoscopic myotomy - A pilot study

      Aims and Objectives:

        -  To study mucosal changes in patients with achalasia cardia

        -  To study potential malignant histopathological findings in long standing achalasia
           cardia

        -  To assess reversibility of mucosal changes after POEM

        -  To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis

        -  To study muscle biopsy by light microscopy and electron microscopy for viral inclusions

      Materials and Methods:

        -  Study Area - Patients of achalasia cardia undergoing POEM in Asian Institute of
           Gastroenterology.

        -  Study Design - Cross sectional study

      Inclusion Criteria:

      •All patients of achalasia cardia who will undergo POEM and an esophageal mucosal biopsy at 3
      months of follow up

      Exclusion Criteria:

        -  Patients of achalasia cardia not undergoing POEM or an esophageal mucosal biopsy at 3
           months of follow up

        -  Upper gastro-intestinal surgically altered anatomy ( apart from previous Heller Myotomy
           )

        -  Pregnancy

        -  Patients not giving consent for participation

        -  End Point( Length of follow up )- 3 months after POEM - single follow up.

      Study Procedure:

      Before POEM, all patients will undergo symptom evaluation, esophagogastroduodenoscopy (EGD),
      high resolution esophageal manometry and timed barium esophagogram.The diagnosis of achalasia
      will be based on a combination of clinical presentation, esophagogastroduodenoscopy, barium
      esophagogram and high resolution manometric findings.

      Symptoms will be classified by using the Eckardt score.Type of Achalasia will be classified
      according to the Chicago classification. Esophagus shape (sigmoid vs nonsigmoid), presence of
      hiatus hernia, presence of esophagitis will be assessed on esophagogastroduodenoscopy.
      Duration since first symptoms of achalasia will be recorded.

      All patients fulfilling the inclusion criteria will undergo Per Oral Endoscopic Myotomy
      (POEM). During POEM, a mucosal biopsy and a muscle biopsy of the Esophagus will be taken.
      Patients will be followed up at a single time, 3 months after POEM. During the follow up
      visit, patients will undergo esophagogastroduodenoscopy guided mucosal biopsy of the
      Esophagus. Patients will be divided into two groups based on the duration of symptoms of
      achalasia- Those having symptoms for 1 year or less and those having symptoms for more than 5
      years. Histopathological changes in the Esophagus and reversibility of these changes after
      POEM will be compared between the two study groups to draw a conclusion.
Introduction and Background:

      Achalasia cardiais a rare, chronic, esophageal motility disorder with an estimated annual
      prevalence of 1 per 1,00,000 subjects. The disease can occur at all ages, but the incidence
      seems to increase with age. The predominant symptoms are dysphagia and regurgitation, because
      of the impaired relaxation of the lower esophageal sphincter (LES) and the loss of normal
      peristalsis.Achalasia is a neurodegenerative disease resulting from an inflammatory and/or
      autoimmune process ultimately leading to aganglionosis. The etiology and pathogenesis of
      achalasia is still unknown. The primary pathophysiologic abnormality is a loss of the
      intrinsic inhibitory innervation of the lower esophageal sphincter (LES) and the segment of
      smooth musculature of the esophageal body. The resultant denervation and reduction of
      post-ganglionic nerve fibers have been postulated to be related to the hypertensive or
      non-relaxing LES in patients with achalasia.Esophagectomy or surgical myotomy specimens have
      demonstratedabsence or reduction in ganglion cells as well as varying degrees of cytotoxic
      T-cell inflammation in the myenteric plexus of patients with achalasia. Studies demonstrating
      an association between achalasia and certain HLA phenotypes, and an increased immunologic
      response to Herpes Simplex Virus-1 (HSV-1) in the serum and LES myenteric plexusof achalasia
      patients further support the notion of inflammation playing a central role in
      pathogenesis.However, it is not known whether this inflammation is part of the process that
      leads to the loss of the plexus, or whether it is secondary to the outflow obstruction with
      consecutive stasis in achalasia. Persistent esophageal distension with retention of foods and
      fluids, bacterial overgrowth, and impaired clearance of regurgitated acid and gastric
      contents lead to chronic inflammation and passively cause dysplasia and carcinoma. The
      prognosis of patients who develop such carcinomas remains poor. The aim of therapy is to
      reduce food stasis, which might interrupt the progression to carcinoma and thus reduce the
      risk of squamous cell carcinoma.

      No currently available treatment options result in regeneration of myenteric neurons to bring
      back esophageal motility. However, lowering LES pressure can significantly reduce symptoms
      and improve quality of life. To achieve this outcome (LES pressure reduction), therapeutic
      techniques have been modified from time to time. Graded pneumatic balloon dilatation (PBD)
      has replaced conventional one-time dilatation and open Heller's myotomy has cleared the way
      for laparoscopic Heller's myotomy (LHM) with fundoplication.Recently, per oral endoscopic
      myotomy (POEM) was introduced by Inoue et al. as a less invasive and effective curative
      treatment option with minimal complications.Peroral endoscopic myotomy (POEM)combines
      thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive
      procedure.Other therapeutic options include endoscopic balloon dilatation and surgical
      myotomy. Endoscopic balloon dilatation is still widely performed because of its relative
      non-invasiveness and simplicity, but it has a relatively lower success rate and often
      requires multiple treatment sessions. Surgical myotomy has been thought to be the curative
      therapeutic choice for symptomatic achalasia. However, it requires skin incisions and
      additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the
      anatomical integrity of the LES and possibly minimizes postoperative reflux.

      Rationale of the study:

        -  There have been very few studies systematically analysing the histopathological changes
           in the mucosa and muscle of the Esophagus in Achalasia Cardia.

        -  Therefore we want to study the histopathological changes in the mucosa and muscle of the
           Esophagus in achalasia cardia patients and observe how the histopathological changes
           differ between early achalasia cardia and long-standing achalasia cardia.

        -  Achalasia Cardia is a potential pre-malignant condition which can lead to esophageal
           carcinoma.

        -  Principal investogator want to study the pre-malignant and malignant changes in the
           Esophagus in achalasia cardia patients.

        -  Also want to study whether per oral endoscopic myotomy ( POEM ) reverses the
           histopathological and pre-malignant changes in the Esophagus.
observational model: Case-Control
time perspective: Cross-Sectional
measure: 1.To study mucosal changes in patients with achalasia cardia
time frame: 12 weeks
description: Number of ganglion cells will be measured in the mucosal biopsy (normal number of ganglion cells are 2 to 12 per mm on Histopathological examination). The size of the ganglion cells will be measured.(normal size of ganglion cells is 10 to 40 microns). Median number of neurons will be measured.(normal median number of neurons are 2 to 6 on histopathological examination).
measure: 2. To study potential malignant histopathological findings in long standing achalasia cardia
time frame: 12 weeks
description: The mean Ki-67 and mean p53 positive ratio will be measured in the histopathological examination.
measure: 3.To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis
time frame: 12 weeks
description: The fibrosis score will be measured in the histopathological examination.
measure: 4. To evaluate reversibility of mucosal changes after per oral endoscopic myotomy (POEM )
time frame: 12 weeks
description: Number of ganglion cells will be measured in the mucosal biopsy (normal number of ganglion cells are 2 to 12 per mm on Histopathological examination). The size of the ganglion cells will be measured.(normal size of ganglion cells is 10 to 40 microns). Median number of neurons will be measured.(normal median number of neurons are 2 to 6 on histopathological examination). These findings will be measured 12 weeks post POEM.
intervention type: Procedure
intervention name: PER ORAL ENDOSCOPY MYOTOMY (POEM)
description: Peroral endoscopic myotomy (POEM)combines thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive procedure.Other therapeutic options include endoscopic balloon dilatation and surgical myotomy. Endoscopic balloon dilatation is still widely performed because of its relative non-invasiveness and simplicity, but it has a relatively lower success rate and often requires multiple treatment sessions. Surgical myotomy has been thought to be the curative therapeutic choice for symptomatic achalasia. However, it requires skin incisions and additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the anatomical integrity of the LES and possibly minimizes postoperative reflux.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Pranav Milind Ambardekar, MBBS MD
role: Principal Investigator
affiliation: Asian institute of Gastroenterology/AIG Hospitals
last name: Dr Pranav Milind Ambardekar, MBBS MD
phone: 04023378888
email: pranavambardekar@gmail.com
last name: Mr Rajesh Goud Maragoni, MPharma, MBA
phone: 04023378888
email: rajeshgoud761@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Asian Institute of Gastroenterology, India
investigator full name: Mohan Ramchandani
investigator title: Dr
mesh term: Esophageal Achalasia
sharing ipd: No