<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/NCT03012854</url>
  </required_header>
  <id_info>
    <org_study_id>NFEC-2016-186</org_study_id>
    <nct_id>NCT03012854</nct_id>
  </id_info>
  <brief_title>Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia</brief_title>
  <official_title>Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the clinical efficacy of safety of circular myotomy and full-thickness&#xD;
      myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in&#xD;
      achalasia patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence&#xD;
      of esophageal peristalsis combined with a defective relaxation of the lower esophageal&#xD;
      sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and&#xD;
      regurgitation of undigested food.&#xD;
&#xD;
      Currently, treatment options mainly focus on relief of the symptoms by reducing the LES&#xD;
      pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia.&#xD;
      However, the patients need repeat treatment to maintain therapeutic success and there is a&#xD;
      risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM)&#xD;
      combined with Dor's antireflux procedure has gained considerable interest. The LHM can&#xD;
      sustain therapeutic effects for long-term in approximately 80% of patients.&#xD;
&#xD;
      Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called&#xD;
      peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically,&#xD;
      POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic&#xD;
      submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal&#xD;
      injection, and then an endoscopic myotomy was made at the gastroesophageal junction.&#xD;
&#xD;
      However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy&#xD;
      guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia&#xD;
      patients were not determined, and there was no prospective study that compared different&#xD;
      surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the&#xD;
      clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral&#xD;
      endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic success</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
    <description>Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of &lt;5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of &gt;10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure related complication</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
    <description>Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of treatment failure</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
    <description>Time of treatment failure is defined as when the Eckardt score of patients are more than 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure at the lower esophageal sphincter</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
    <description>From date of randomization until the follow-up ended, assessed up to 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
    <description>Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Esophageal Achalasia</condition>
  <condition>Esophageal Motility Disorders</condition>
  <arm_group>
    <arm_group_label>short-myotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short-POEM for patients with esophageal achalasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>long-myotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Long-POEM for patients with esophageal achalasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>full-thickness myotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Full-thickness-POEM for patients with esophageal achalasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>circular myotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Circular-POEM for patients with esophageal achalasia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>short-myotomy</intervention_name>
    <description>Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).&#xD;
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.&#xD;
Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.&#xD;
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.&#xD;
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.</description>
    <arm_group_label>short-myotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>long-myotomy</intervention_name>
    <description>Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).&#xD;
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.&#xD;
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.&#xD;
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.&#xD;
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.</description>
    <arm_group_label>long-myotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>full-thickness myotomy</intervention_name>
    <description>Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).&#xD;
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.&#xD;
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.&#xD;
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.&#xD;
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.</description>
    <arm_group_label>full-thickness myotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>circular myotomy</intervention_name>
    <description>Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).&#xD;
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.&#xD;
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.&#xD;
Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact.&#xD;
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.</description>
    <arm_group_label>circular myotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 18 and 75 years of age;&#xD;
&#xD;
          2. Patient with esophageal achalasia;&#xD;
&#xD;
          3. Eckardt score &gt; 3;&#xD;
&#xD;
          4. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe cardio-pulmonary disease or other serious disease leading to unacceptable&#xD;
             surgical risk;&#xD;
&#xD;
          2. Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in&#xD;
             the distal oesophagus;&#xD;
&#xD;
          3. Previous endoscopic Botox injection;&#xD;
&#xD;
          4. Previous oesophageal or gastric surgery;&#xD;
&#xD;
          5. Pregnancy or lactation women, or ready to pregnant women;&#xD;
&#xD;
          6. Not capable of filling out questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Gong, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Gong, Doctor</last_name>
    <phone>86-15820290385</phone>
    <email>drgwei@foxmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Silin Huang, Master</last_name>
    <phone>86-13512756686</phone>
    <email>13816757@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Gong, Doctor</last_name>
      <phone>86-15820290385</phone>
      <email>drgwei@foxmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Silin Huang, Master</last_name>
      <phone>86-13512756686</phone>
      <email>13816757@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Wei Gong, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silin Huang, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Liyun Huang, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hui Yue, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jianuan Wu, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaobing Cui, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.nfyy.com/</url>
    <description>Homepage of Nanfang Hospital of Southern Medical University</description>
  </link>
  <link>
    <url>http://www.xhbnet.com/</url>
    <description>Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University</description>
  </link>
  <reference>
    <citation>Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.</citation>
    <PMID>20354937</PMID>
  </reference>
  <reference>
    <citation>Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.</citation>
    <PMID>21561346</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Wei Gong</investigator_full_name>
    <investigator_title>Doctor of Medicine，Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Esophageal achalasia</keyword>
  <keyword>Peroral endoscopic myotomy</keyword>
  <keyword>POEM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Achalasia</mesh_term>
    <mesh_term>Esophageal Motility Disorders</mesh_term>
    <mesh_term>Esophageal Spasm, Diffuse</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/NCT03012854
org study id: NFEC-2016-186
nct id: NCT03012854
lead sponsor: 
has dmc: Yes
This study compares the clinical efficacy of safety of circular myotomy and full-thickness
      myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in
      achalasia patients.
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence
      of esophageal peristalsis combined with a defective relaxation of the lower esophageal
      sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and
      regurgitation of undigested food.

      Currently, treatment options mainly focus on relief of the symptoms by reducing the LES
      pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia.
      However, the patients need repeat treatment to maintain therapeutic success and there is a
      risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM)
      combined with Dor's antireflux procedure has gained considerable interest. The LHM can
      sustain therapeutic effects for long-term in approximately 80% of patients.

      Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called
      peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically,
      POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic
      submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal
      injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

      However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy
      guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia
      patients were not determined, and there was no prospective study that compared different
      surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the
      clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral
      endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Therapeutic success
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
description: Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of <5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of >10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
measure: Procedure related complication
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
description: Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
measure: Time of treatment failure
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
description: Time of treatment failure is defined as when the Eckardt score of patients are more than 3.
measure: Pressure at the lower esophageal sphincter
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
description: From date of randomization until the follow-up ended, assessed up to 5 years
measure: Quality of life
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
description: Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life.
arm group label: short-myotomy
arm group type: Experimental
description: Short-POEM for patients with esophageal achalasia
arm group label: long-myotomy
arm group type: Active Comparator
description: Long-POEM for patients with esophageal achalasia
arm group label: full-thickness myotomy
arm group type: Experimental
description: Full-thickness-POEM for patients with esophageal achalasia
arm group label: circular myotomy
arm group type: Active Comparator
description: Circular-POEM for patients with esophageal achalasia
intervention type: Procedure
intervention name: short-myotomy
description: Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
arm group label: short-myotomy
intervention type: Procedure
intervention name: long-myotomy
description: Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
arm group label: long-myotomy
intervention type: Procedure
intervention name: full-thickness myotomy
description: Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
arm group label: full-thickness myotomy
intervention type: Procedure
intervention name: circular myotomy
description: Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact.
Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
arm group label: circular myotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wei Gong, Doctor
role: Principal Investigator
affiliation: Nanfang Hospital, Southern Medical University
last name: Wei Gong, Doctor
phone: 86-15820290385
email: drgwei@foxmail.com
last name: Silin Huang, Master
phone: 86-13512756686
email: 13816757@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
url: http://www.nfyy.com/
description: Homepage of Nanfang Hospital of Southern Medical University
url: http://www.xhbnet.com/
description: Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University
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: Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
PMID: 21561346
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Wei Gong
investigator title: Doctor of Medicine，Associate Professor
mesh term: Esophageal Achalasia
mesh term: Esophageal Motility Disorders
mesh term: Esophageal Spasm, Diffuse
sharing ipd: No