<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/NCT03228758</url>
  </required_header>
  <id_info>
    <org_study_id>WUH 17008</org_study_id>
    <secondary_id>18-01666</secondary_id>
    <nct_id>NCT03228758</nct_id>
  </id_info>
  <brief_title>Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia</brief_title>
  <official_title>Efficacy of Anterior Versus Posterior Myotomy Approach in Per Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia - A Single Operator Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      The purpose of this study is to compare the safety and efficacy of the anterior versus&#xD;
      posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of&#xD;
      Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of&#xD;
      narcotics. The secondary outcomes focus on safety which includes technical procedure duration&#xD;
      time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and&#xD;
      non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal&#xD;
      reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure&#xD;
      pain scores, administrations of analgesia until discharge.&#xD;
&#xD;
      The final analysis will focus on determining whether there is a statistically significant&#xD;
      difference in the amount and severity of pain in the Anterior versus Posterior myotomy&#xD;
      subject populations. Additional analysis will be the collection of analgesic type (narcotic&#xD;
      versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure&#xD;
      in the endoscopy recovery suite until the subjects are discharged.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achalasia is one of the most studied esophageal motility disorders. The etiology of Achalasia&#xD;
      is autoimmune, neurodegenerative, or viral immune. Achalasia is a consequence of the&#xD;
      degeneration of ganglion cells in the myenteric plexus of the esophageal body and the lower&#xD;
      esophageal sphincter (LES). The end result of the inflammatory process is the loss of&#xD;
      inhibitory neurotransmitters nitrous oxide and vasoactive intestinal peptide causing the&#xD;
      imbalance between excitatory and inhibitory neurons. This results in failure of the lower&#xD;
      esophageal sphincter (LES) to relax and is associated with aperistalsis of the esophageal&#xD;
      body, leading to difficulty swallowing, food and fluid stasis; regurgitation of undigested&#xD;
      food, fluid and saliva; and weight loss. Achalasia is an incurable disease and treatments are&#xD;
      only focused on the relaxation of the lower esophageal sphincter in order to allow for&#xD;
      passage of food fluid and saliva into the stomach. It has an estimated prevalence of 10 cases&#xD;
      per 100,000 populations and an incidence of 1-3 cases per 100,000 populations per year in the&#xD;
      Western world.&#xD;
&#xD;
      The armamentarium of Achalasia treatment includes pharmacologic management with the use of&#xD;
      calcium channel blockers, nitrites, phosphodiesterase inhibitor (sildenafil),&#xD;
      anticholinergics, and beta-adrenergic agonists; endoscopy using botulinum toxin injections&#xD;
      just above the squamocolumnar junction or pneumatic balloon dilation of the lower esophageal&#xD;
      sphincter; open Heller Myotomy, laparoscopic Heller Myotomy, and Per Oral Endoscopic myotomy&#xD;
      (POEM). Per oral endoscopic myotomy (POEM) is the most recent innovative treatment in the&#xD;
      armamentarium of Achalasia treatment. Per oral endoscopic myotomy (POEM) is a natural orifice&#xD;
      transluminal endoscopic surgery (NOTES) approach to a Heller myotomy for the treatment of&#xD;
      Achalasia. In 2008, POEM was first performed successfully in a human subject by Haruhiro&#xD;
      Inoue in Japan. The POEM was performed on a 36 year old patient without any documented&#xD;
      post-operative complications. In 2009, Stavros Stavropoulos at Winthrop University Hospital&#xD;
      (WUH) performed the first per oral endoscopic myotomy (POEM) procedure outside of Japan. The&#xD;
      POEM was performed on a 42 year old male without documented post-operative complications. The&#xD;
      subject had a marked improvement in objective manometric and barium esophagram findings; and&#xD;
      improvement in subjective dysphagia score. Consequently there has been a rapidly increasing&#xD;
      volume of POEM procedures performed in Japan, China, and throughout the United States.&#xD;
      Stavropoulos at Winthrop University Hospital has the highest single-operator volume in the&#xD;
      United States. The performance of POEM is still in evolution with various centers around the&#xD;
      world performing variations on technique.&#xD;
&#xD;
      The International Per Oral Endoscopic Myotomy Survey (IPOEMS) was conducted by Stavropoulos&#xD;
      and Savides during the July 2012 annual meeting of Natural Orifice Surgery Consortium for&#xD;
      Assessment and Research (NOSCAR). This survey was conducted to address the scarceness of POEM&#xD;
      literature at the time. IPOEM provided a &quot;snapshot&quot; of the status of POEM worldwide. The&#xD;
      survey included 5 Asian, 7 North American, and 4 European expert centers with a combined&#xD;
      total of 841 POEM procedures performed by July 2012. At the time most centers (14) performed&#xD;
      right anterior myotomy (2 o'clock orientation) with only a few of centers performing&#xD;
      posterolateral myotomy (5 o'clock orientation) determined using the usual endoscopic&#xD;
      convention of 12 o'clock representing the most anterior aspect of the esophagus on&#xD;
      endoluminal view.&#xD;
&#xD;
      The esophagus in humans is a complex structure with multiple muscles, nerves, vascular, and&#xD;
      lymphatic components. Branches of the vagus nerve and visceral branches of the sympathetic&#xD;
      trunk provide nerve fibers to the esophageal plexus. The vagus nerve delivers two fiber types&#xD;
      to the esophageal plexus: preganglionic parasympathetic fibers and afferent fibers. These&#xD;
      vagal fibers in the esophageal plexus reform to make the anterior vagal trunk (left vagus)&#xD;
      and the posterior vagal trunk (right vagus). The anterior and posterior terms for the vagal&#xD;
      trunks are used in relation to the esophagus. The visceral branches of the sympathetic trunk&#xD;
      delivers two fiber types to the esophageal plexus: sympathetic postganglionic fibers and the&#xD;
      afferent fibers. The afferent fibers originating from the sympathetic trunk are primarily&#xD;
      involved with pain. The critical anatomical component of the esophagus in the treatment of&#xD;
      Achalasia is the lower esophageal sphincter. Per common convention, the most anterior point&#xD;
      of the LES point is assigned as the 12 o'clock position. The strong oblique sling fiber&#xD;
      component is centered at 7o'clock on the posterolateral wall and wraps over the anterior and&#xD;
      posterior walls at 11 o'clock and 5 o'clock, respectively. The weaker circular clasp fiber&#xD;
      component location is centered at 2 o'clock to 3 o'clock. The question of investigating the&#xD;
      optimal orientation to perform the myotomy is unique to POEM. Open Heller myotomy and&#xD;
      laparoscopic Heller myotomy are limited to the anterior aspect of the esophagus. Myotomy&#xD;
      orientation is constrained by the anatomical locations of the left bronchus, left atrium and&#xD;
      spine. Anterior orientation is forced between the 1 o'clock - 2 o'clock position secondary to&#xD;
      the locations of the left bronchus and left atrium between 10 o'clock -11 o'clock and 12&#xD;
      o'clock - 1 o'clock, respectively. Posterior orientation is forced between the 4 o'clock - 5&#xD;
      o'clock positions secondary to the location of the spine located between 8 o'clock-9 o'clock&#xD;
      positions .The sling fibers maintain the angle of His and are a significant antireflux&#xD;
      barrier. Stavropoulos et al, reported on a single operator series of 284 POEM subjects at&#xD;
      Digestive Disease Week in May 2016. A statistical difference was found in the number of&#xD;
      subjects requiring narcotics post POEM procedure Subjects who had an anterior myotomy were&#xD;
      less likely to require narcotics post POEM procedure than those subjects who had a posterior&#xD;
      myotomy, 35% versus 53% respectively (p=0.007).&#xD;
&#xD;
      To date, there have been no prospective randomized controlled studies conducted comparing&#xD;
      anterior versus posterior myotomy technique in POEM analyzing perioperative pain, procedure&#xD;
      duration, incidence of mucosotomy, capnoperitoneum, and the postoperative sequelae of&#xD;
      gastrointestinal reflux disease (GERD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">May 24, 2019</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</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>
    <intervention_model_description>Subjects will be randomized to either the anterior or posterior orientation approach to the endoscopic myotomy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects will not be made aware of the orientation approach to the endoscopic myotomy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Periprocedural pain requiring the use of narcotics.</measure>
    <time_frame>Within the first 48 hours after the procedure.</time_frame>
    <description>Pain related to the endoscopic myotomy requiring the use of narcotic pain medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Gastrointestinal Reflux Disease (GERD)</measure>
    <time_frame>Within 3 months after the procedure.</time_frame>
    <description>Gastrointestinal Reflux Disease measured by BRAVO pH study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Achalasia</condition>
  <arm_group>
    <arm_group_label>Anterior Orientation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 11 o'clock to 3 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.&#xD;
Intervention is the endoscopic myotomy of the lower esophageal sphincter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Posterior Orientation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The posterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 5 o'clock to 6 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.&#xD;
Intervention is the endoscopic myotomy of the lower esophageal sphincter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Per Oral Endoscopic Myotomy</intervention_name>
    <description>The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)</description>
    <arm_group_label>Anterior Orientation</arm_group_label>
    <arm_group_label>Posterior Orientation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have been diagnosed with Achalasia Type I, II, or III by positive&#xD;
             manometric findings and supporting findings by timed barium esophagram and endoscopy.&#xD;
&#xD;
          2. Subjects who are willing and competent to sign Informed Consent and to comply with&#xD;
             study related visits and procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are under 18 years of age&#xD;
&#xD;
          2. Subjects with Achalasia Type I, II, or III who have had a prior failed open or&#xD;
             laparoscopic Heller myotomy; or have an esophageal diverticula, or anatomical variant&#xD;
             dictating the approach of the myotomy&#xD;
&#xD;
          3. Subjects diagnosed with other motility disorders such as distal esophageal spasm&#xD;
             (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus&#xD;
             (Jackhammer)&#xD;
&#xD;
          4. Subjects with coagulopathy&#xD;
&#xD;
          5. Pregnant females&#xD;
&#xD;
          6. Subjects who in the investigators' opinion, are medically unstable , are unable to&#xD;
             give informed consent, or whose risks outweigh the benefits of participating in the&#xD;
             study&#xD;
&#xD;
          7. Subjects with decisional incapacity who are unable to comply with study related visits&#xD;
             and procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stavros Stavropoulos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Winthrop</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Nguyen NQ, Holloway RH. Recent developments in esophageal motor disorders. Curr Opin Gastroenterol. 2005 Jul;21(4):478-84.</citation>
    <PMID>15930992</PMID>
  </results_reference>
  <results_reference>
    <citation>Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.</citation>
    <PMID>23877351</PMID>
  </results_reference>
  <results_reference>
    <citation>Walzer N, Hirano I. Achalasia. Gastroenterol Clin North Am. 2008 Dec;37(4):807-25, viii. doi: 10.1016/j.gtc.2008.09.002.</citation>
    <PMID>19028319</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruffato A, Mattioli S, Lugaresi ML, D'Ovidio F, Antonacci F, Di Simone MP. Long-term results after Heller-Dor operation for oesophageal achalasia. Eur J Cardiothorac Surg. 2006 Jun;29(6):914-9. doi: 10.1016/j.ejcts.2006.03.044. Epub 2006 May 3.</citation>
    <PMID>16675239</PMID>
  </results_reference>
  <results_reference>
    <citation>Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042.</citation>
    <PMID>24074429</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Richter JE. Update on the management of achalasia: balloons, surgery and drugs. Expert Rev Gastroenterol Hepatol. 2008 Jun;2(3):435-45. doi: 10.1586/17474124.2.3.435.</citation>
    <PMID>19072391</PMID>
  </results_reference>
  <results_reference>
    <citation>Stavropoulos SN, Harris MD, Hida S, Brathwaite C, Demetriou C, Grendell J. Endoscopic submucosal myotomy for the treatment of achalasia (with video). Gastrointest Endosc. 2010 Dec;72(6):1309-11. doi: 10.1016/j.gie.2010.04.016. No abstract available.</citation>
    <PMID>21111876</PMID>
  </results_reference>
  <results_reference>
    <citation>Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3.</citation>
    <PMID>23549760</PMID>
  </results_reference>
  <results_reference>
    <citation>Stavropoulos, SN, Modayil, R, and Brathwaite, et al. Anterior vs. posterior per oral endoscopic myotomy (POEM): Is there a difference in outcome? Gastrointest Endosc 2016; 83 (5S): AB145</citation>
  </results_reference>
  <results_reference>
    <citation>Friedel D, Modayil R, Stavropoulos SN. Per Oral Endoscopic Myotomy (POEM): review of current techniques and outcomes (including postoperative reflux). Curr Surg Rep 2013; 1: 203-213.</citation>
  </results_reference>
  <results_reference>
    <citation>Stranding, S. (2016) Mediastinum, In Gray's anatomy: the anatomical basis of clinical practice. (41st Ed.). (pp. 976-993) Elsevier Limited in Clinical Key Flex</citation>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>May 4, 2020</last_update_submitted>
  <last_update_submitted_qc>May 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>POEM</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/NCT03228758
org study id: WUH 17008
secondary id: 18-01666
nct id: NCT03228758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the safety and efficacy of the anterior versus
      posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of
      Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of
      narcotics. The secondary outcomes focus on safety which includes technical procedure duration
      time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and
      non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal
      reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure
      pain scores, administrations of analgesia until discharge.

      The final analysis will focus on determining whether there is a statistically significant
      difference in the amount and severity of pain in the Anterior versus Posterior myotomy
      subject populations. Additional analysis will be the collection of analgesic type (narcotic
      versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure
      in the endoscopy recovery suite until the subjects are discharged.
Achalasia is one of the most studied esophageal motility disorders. The etiology of Achalasia
      is autoimmune, neurodegenerative, or viral immune. Achalasia is a consequence of the
      degeneration of ganglion cells in the myenteric plexus of the esophageal body and the lower
      esophageal sphincter (LES). The end result of the inflammatory process is the loss of
      inhibitory neurotransmitters nitrous oxide and vasoactive intestinal peptide causing the
      imbalance between excitatory and inhibitory neurons. This results in failure of the lower
      esophageal sphincter (LES) to relax and is associated with aperistalsis of the esophageal
      body, leading to difficulty swallowing, food and fluid stasis; regurgitation of undigested
      food, fluid and saliva; and weight loss. Achalasia is an incurable disease and treatments are
      only focused on the relaxation of the lower esophageal sphincter in order to allow for
      passage of food fluid and saliva into the stomach. It has an estimated prevalence of 10 cases
      per 100,000 populations and an incidence of 1-3 cases per 100,000 populations per year in the
      Western world.

      The armamentarium of Achalasia treatment includes pharmacologic management with the use of
      calcium channel blockers, nitrites, phosphodiesterase inhibitor (sildenafil),
      anticholinergics, and beta-adrenergic agonists; endoscopy using botulinum toxin injections
      just above the squamocolumnar junction or pneumatic balloon dilation of the lower esophageal
      sphincter; open Heller Myotomy, laparoscopic Heller Myotomy, and Per Oral Endoscopic myotomy
      (POEM). Per oral endoscopic myotomy (POEM) is the most recent innovative treatment in the
      armamentarium of Achalasia treatment. Per oral endoscopic myotomy (POEM) is a natural orifice
      transluminal endoscopic surgery (NOTES) approach to a Heller myotomy for the treatment of
      Achalasia. In 2008, POEM was first performed successfully in a human subject by Haruhiro
      Inoue in Japan. The POEM was performed on a 36 year old patient without any documented
      post-operative complications. In 2009, Stavros Stavropoulos at Winthrop University Hospital
      (WUH) performed the first per oral endoscopic myotomy (POEM) procedure outside of Japan. The
      POEM was performed on a 42 year old male without documented post-operative complications. The
      subject had a marked improvement in objective manometric and barium esophagram findings; and
      improvement in subjective dysphagia score. Consequently there has been a rapidly increasing
      volume of POEM procedures performed in Japan, China, and throughout the United States.
      Stavropoulos at Winthrop University Hospital has the highest single-operator volume in the
      United States. The performance of POEM is still in evolution with various centers around the
      world performing variations on technique.

      The International Per Oral Endoscopic Myotomy Survey (IPOEMS) was conducted by Stavropoulos
      and Savides during the July 2012 annual meeting of Natural Orifice Surgery Consortium for
      Assessment and Research (NOSCAR). This survey was conducted to address the scarceness of POEM
      literature at the time. IPOEM provided a "snapshot" of the status of POEM worldwide. The
      survey included 5 Asian, 7 North American, and 4 European expert centers with a combined
      total of 841 POEM procedures performed by July 2012. At the time most centers (14) performed
      right anterior myotomy (2 o'clock orientation) with only a few of centers performing
      posterolateral myotomy (5 o'clock orientation) determined using the usual endoscopic
      convention of 12 o'clock representing the most anterior aspect of the esophagus on
      endoluminal view.

      The esophagus in humans is a complex structure with multiple muscles, nerves, vascular, and
      lymphatic components. Branches of the vagus nerve and visceral branches of the sympathetic
      trunk provide nerve fibers to the esophageal plexus. The vagus nerve delivers two fiber types
      to the esophageal plexus: preganglionic parasympathetic fibers and afferent fibers. These
      vagal fibers in the esophageal plexus reform to make the anterior vagal trunk (left vagus)
      and the posterior vagal trunk (right vagus). The anterior and posterior terms for the vagal
      trunks are used in relation to the esophagus. The visceral branches of the sympathetic trunk
      delivers two fiber types to the esophageal plexus: sympathetic postganglionic fibers and the
      afferent fibers. The afferent fibers originating from the sympathetic trunk are primarily
      involved with pain. The critical anatomical component of the esophagus in the treatment of
      Achalasia is the lower esophageal sphincter. Per common convention, the most anterior point
      of the LES point is assigned as the 12 o'clock position. The strong oblique sling fiber
      component is centered at 7o'clock on the posterolateral wall and wraps over the anterior and
      posterior walls at 11 o'clock and 5 o'clock, respectively. The weaker circular clasp fiber
      component location is centered at 2 o'clock to 3 o'clock. The question of investigating the
      optimal orientation to perform the myotomy is unique to POEM. Open Heller myotomy and
      laparoscopic Heller myotomy are limited to the anterior aspect of the esophagus. Myotomy
      orientation is constrained by the anatomical locations of the left bronchus, left atrium and
      spine. Anterior orientation is forced between the 1 o'clock - 2 o'clock position secondary to
      the locations of the left bronchus and left atrium between 10 o'clock -11 o'clock and 12
      o'clock - 1 o'clock, respectively. Posterior orientation is forced between the 4 o'clock - 5
      o'clock positions secondary to the location of the spine located between 8 o'clock-9 o'clock
      positions .The sling fibers maintain the angle of His and are a significant antireflux
      barrier. Stavropoulos et al, reported on a single operator series of 284 POEM subjects at
      Digestive Disease Week in May 2016. A statistical difference was found in the number of
      subjects requiring narcotics post POEM procedure Subjects who had an anterior myotomy were
      less likely to require narcotics post POEM procedure than those subjects who had a posterior
      myotomy, 35% versus 53% respectively (p=0.007).

      To date, there have been no prospective randomized controlled studies conducted comparing
      anterior versus posterior myotomy technique in POEM analyzing perioperative pain, procedure
      duration, incidence of mucosotomy, capnoperitoneum, and the postoperative sequelae of
      gastrointestinal reflux disease (GERD).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to either the anterior or posterior orientation approach to the endoscopic myotomy.
primary purpose: Treatment
masking: Single (Participant)
masking description: Subjects will not be made aware of the orientation approach to the endoscopic myotomy.
measure: Periprocedural pain requiring the use of narcotics.
time frame: Within the first 48 hours after the procedure.
description: Pain related to the endoscopic myotomy requiring the use of narcotic pain medication.
measure: Incidence of Gastrointestinal Reflux Disease (GERD)
time frame: Within 3 months after the procedure.
description: Gastrointestinal Reflux Disease measured by BRAVO pH study
arm group label: Anterior Orientation
arm group type: Active Comparator
description: The anterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 11 o'clock to 3 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.
Intervention is the endoscopic myotomy of the lower esophageal sphincter.
arm group label: Posterior Orientation
arm group type: Active Comparator
description: The posterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 5 o'clock to 6 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.
Intervention is the endoscopic myotomy of the lower esophageal sphincter.
intervention type: Procedure
intervention name: Per Oral Endoscopic Myotomy
description: The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)
arm group label: Anterior Orientation
arm group label: Posterior Orientation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stavros Stavropoulos, MD
role: Principal Investigator
affiliation: NYU Langone Winthrop
facility: 
country: United States
citation: Nguyen NQ, Holloway RH. Recent developments in esophageal motor disorders. Curr Opin Gastroenterol. 2005 Jul;21(4):478-84.
PMID: 15930992
citation: Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.
PMID: 23877351
citation: Walzer N, Hirano I. Achalasia. Gastroenterol Clin North Am. 2008 Dec;37(4):807-25, viii. doi: 10.1016/j.gtc.2008.09.002.
PMID: 19028319
citation: Ruffato A, Mattioli S, Lugaresi ML, D'Ovidio F, Antonacci F, Di Simone MP. Long-term results after Heller-Dor operation for oesophageal achalasia. Eur J Cardiothorac Surg. 2006 Jun;29(6):914-9. doi: 10.1016/j.ejcts.2006.03.044. Epub 2006 May 3.
PMID: 16675239
citation: Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042.
PMID: 24074429
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: Richter JE. Update on the management of achalasia: balloons, surgery and drugs. Expert Rev Gastroenterol Hepatol. 2008 Jun;2(3):435-45. doi: 10.1586/17474124.2.3.435.
PMID: 19072391
citation: Stavropoulos SN, Harris MD, Hida S, Brathwaite C, Demetriou C, Grendell J. Endoscopic submucosal myotomy for the treatment of achalasia (with video). Gastrointest Endosc. 2010 Dec;72(6):1309-11. doi: 10.1016/j.gie.2010.04.016. No abstract available.
PMID: 21111876
citation: Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3.
PMID: 23549760
citation: Stavropoulos, SN, Modayil, R, and Brathwaite, et al. Anterior vs. posterior per oral endoscopic myotomy (POEM): Is there a difference in outcome? Gastrointest Endosc 2016; 83 (5S): AB145
citation: Friedel D, Modayil R, Stavropoulos SN. Per Oral Endoscopic Myotomy (POEM): review of current techniques and outcomes (including postoperative reflux). Curr Surg Rep 2013; 1: 203-213.
citation: Stranding, S. (2016) Mediastinum, In Gray's anatomy: the anatomical basis of clinical practice. (41st Ed.). (pp. 976-993) Elsevier Limited in Clinical Key Flex
responsible party type: Sponsor
mesh term: Esophageal Achalasia