<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/NCT03040817</url>
  </required_header>
  <id_info>
    <org_study_id>GI of ZhongdaH</org_study_id>
    <nct_id>NCT03040817</nct_id>
  </id_info>
  <brief_title>Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China</brief_title>
  <official_title>Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary&#xD;
      pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is&#xD;
      limited medical therapeutic options for these diseases. Gastric peroral endoscopic&#xD;
      pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a&#xD;
      minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases&#xD;
      are rarely explored. So, there is a cooperative group composed of five clinical centers for&#xD;
      clinical research in G-POEM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are randomly devided into 'G-POEM group' and 'Esomeprazole+Mosapride group'. In&#xD;
      G-POEM group, each participant receives G-POEM treatment. In Esomeprazole+Mosapride group,&#xD;
      each participant receives Nexium 40mg bid + Mosapride Citrate Tablets 5mg tid. The whole&#xD;
      outcome measure time fram is up to two years. Outcome evaluations include: gastric emptying&#xD;
      imaging, gastric antrum volume, gastric emptying time, gastroparesis cardinal symptoms index&#xD;
      and gastroesophageal reflux disease questionnaire. All the outcomes are assessed at different&#xD;
      time points (from baseline to 6 months, 12months and 24months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 16, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 16, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Imaging at 6 months.</measure>
    <time_frame>From baseline to 6 months.</time_frame>
    <description>Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Imaging at 12 months.</measure>
    <time_frame>From baseline to 12 months.</time_frame>
    <description>Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Imaging at 24 months.</measure>
    <time_frame>From baseline to 24 months.</time_frame>
    <description>Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Antrum Volume at 6 months.</measure>
    <time_frame>From baseline to 6 months.</time_frame>
    <description>Each participant will receive gastric antrum volume measurement both at baseline and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Antrum Volume at 12 months.</measure>
    <time_frame>From baseline to 12 months.</time_frame>
    <description>Each participant will receive gastric antrum volume measurement both at baseline and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Antrum Volume at 24 months.</measure>
    <time_frame>From baseline to 24 months.</time_frame>
    <description>Each participant will receive gastric antrum volume measurement both at baseline and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Time at 6 months.</measure>
    <time_frame>From baseline to 6 months.</time_frame>
    <description>Each participant will receive gastric emptying time measurement both at baseline and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Time at 12 months.</measure>
    <time_frame>From baseline to 12 months.</time_frame>
    <description>Each participant will receive gastric emptying time measurement both at baseline and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastric Emptying Time at 24 months.</measure>
    <time_frame>From baseline to 24 months.</time_frame>
    <description>Each participant will receive gastric emptying time measurement both at baseline and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.</measure>
    <time_frame>From baseline to 6 months.</time_frame>
    <description>Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.</measure>
    <time_frame>From baseline to 12 months.</time_frame>
    <description>Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.</measure>
    <time_frame>From baseline to 24 months.</time_frame>
    <description>Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.</measure>
    <time_frame>From baseline to 6 months.</time_frame>
    <description>Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.</measure>
    <time_frame>From baseline to 12 months.</time_frame>
    <description>Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.</measure>
    <time_frame>From baseline to 24 months.</time_frame>
    <description>Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)</condition>
  <arm_group>
    <arm_group_label>G-POEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esomeprazole + Mosapride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric peroral endoscopic pyloromyotomy (G-POEM)</intervention_name>
    <description>G-POEM procedure:&#xD;
A. Premixed methylene blue/normal saline were injected into gastric antrum submucosa at greater curvature, 5 cm proximal to the pylorus.&#xD;
B. Submucosal tunnel was created via endoscopic submucosal dissection. C. A white thick pyloric band, was in contrast to a thin-walled submucosal space of the duodenum observed distally.&#xD;
D. Pyloromyotomy starts with dissection of the pyloric ring exposing muscular layer underneath.&#xD;
E. Circular and longitudinal myotomy for 2-3 cm. F. Serosa indicates appropriate depth of myotomy. G. Reevaluation of the mucosotomy site. H. Mucosal entry was closed with clips from distal mucosal incision point.</description>
    <arm_group_label>G-POEM</arm_group_label>
    <other_name>Peroral endoscopic pyloromyotomy (POP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole + Mosapride</intervention_name>
    <description>Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.</description>
    <arm_group_label>Esomeprazole + Mosapride</arm_group_label>
    <other_name>Nexium + Mosapride Citrate Tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 16 to 80 years old&#xD;
&#xD;
          2. Full sufficiency in literacy&#xD;
&#xD;
          3. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks&#xD;
&#xD;
          4. Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe heart, lung, and cerebrovascular disease&#xD;
&#xD;
          2. Severe hematopoietic system disease&#xD;
&#xD;
          3. Abnormal blood coagulation function&#xD;
&#xD;
          4. Oropharyngeal abnormalities&#xD;
&#xD;
          5. Severe spine malformation&#xD;
&#xD;
          6. In pregnancy and lactation at present, or plan to become pregnant within 2 years&#xD;
&#xD;
          7. Severe inflammation or huge ulcers in stomach&#xD;
&#xD;
          8. Mental and psychological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huiping Wang</last_name>
    <role>Study Chair</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruihua Shi, MD,PhD</last_name>
    <phone>+8613951799326</phone>
    <email>ruihuashi@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jiacheng Tan, MD,PhD</last_name>
    <phone>+8615105165989</phone>
    <email>cencen_njjs@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruihua Shi</last_name>
      <email>ruihuashi@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 26, 2017</last_update_submitted>
  <last_update_submitted_qc>August 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Ruihua Shi</investigator_full_name>
    <investigator_title>MD, PhD, Postdoctoral Mentor, Chief Physician</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Mosapride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03040817
org study id: GI of ZhongdaH
nct id: NCT03040817
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary
      pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is
      limited medical therapeutic options for these diseases. Gastric peroral endoscopic
      pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a
      minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases
      are rarely explored. So, there is a cooperative group composed of five clinical centers for
      clinical research in G-POEM.
Participants are randomly devided into 'G-POEM group' and 'Esomeprazole+Mosapride group'. In
      G-POEM group, each participant receives G-POEM treatment. In Esomeprazole+Mosapride group,
      each participant receives Nexium 40mg bid + Mosapride Citrate Tablets 5mg tid. The whole
      outcome measure time fram is up to two years. Outcome evaluations include: gastric emptying
      imaging, gastric antrum volume, gastric emptying time, gastroparesis cardinal symptoms index
      and gastroesophageal reflux disease questionnaire. All the outcomes are assessed at different
      time points (from baseline to 6 months, 12months and 24months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from Baseline in Gastric Emptying Imaging at 6 months.
time frame: From baseline to 6 months.
description: Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.
measure: Change from Baseline in Gastric Emptying Imaging at 12 months.
time frame: From baseline to 12 months.
description: Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.
measure: Change from Baseline in Gastric Emptying Imaging at 24 months.
time frame: From baseline to 24 months.
description: Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.
measure: Change from Baseline in Gastric Antrum Volume at 6 months.
time frame: From baseline to 6 months.
description: Each participant will receive gastric antrum volume measurement both at baseline and 6 months.
measure: Change from Baseline in Gastric Antrum Volume at 12 months.
time frame: From baseline to 12 months.
description: Each participant will receive gastric antrum volume measurement both at baseline and 12 months.
measure: Change from Baseline in Gastric Antrum Volume at 24 months.
time frame: From baseline to 24 months.
description: Each participant will receive gastric antrum volume measurement both at baseline and 24 months.
measure: Change from Baseline in Gastric Emptying Time at 6 months.
time frame: From baseline to 6 months.
description: Each participant will receive gastric emptying time measurement both at baseline and 6 months.
measure: Change from Baseline in Gastric Emptying Time at 12 months.
time frame: From baseline to 12 months.
description: Each participant will receive gastric emptying time measurement both at baseline and 12 months.
measure: Change from Baseline in Gastric Emptying Time at 24 months.
time frame: From baseline to 24 months.
description: Each participant will receive gastric emptying time measurement both at baseline and 24 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.
time frame: From baseline to 6 months.
description: Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.
time frame: From baseline to 12 months.
description: Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.
measure: Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.
time frame: From baseline to 24 months.
description: Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.
time frame: From baseline to 6 months.
description: Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.
time frame: From baseline to 12 months.
description: Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.
time frame: From baseline to 24 months.
description: Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.
arm group label: G-POEM
arm group type: Experimental
description: Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).
arm group label: Esomeprazole + Mosapride
arm group type: Active Comparator
description: Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid.
intervention type: Procedure
intervention name: Gastric peroral endoscopic pyloromyotomy (G-POEM)
description: G-POEM procedure:
A. Premixed methylene blue/normal saline were injected into gastric antrum submucosa at greater curvature, 5 cm proximal to the pylorus.
B. Submucosal tunnel was created via endoscopic submucosal dissection. C. A white thick pyloric band, was in contrast to a thin-walled submucosal space of the duodenum observed distally.
D. Pyloromyotomy starts with dissection of the pyloric ring exposing muscular layer underneath.
E. Circular and longitudinal myotomy for 2-3 cm. F. Serosa indicates appropriate depth of myotomy. G. Reevaluation of the mucosotomy site. H. Mucosal entry was closed with clips from distal mucosal incision point.
arm group label: G-POEM
other name: Peroral endoscopic pyloromyotomy (POP)
intervention type: Drug
intervention name: Esomeprazole + Mosapride
description: Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.
arm group label: Esomeprazole + Mosapride
other name: Nexium + Mosapride Citrate Tablets
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Huiping Wang
role: Study Chair
affiliation: Zhongda Hospital
last name: Ruihua Shi, MD,PhD
phone: +8613951799326
email: ruihuashi@126.com
last name: Jiacheng Tan, MD,PhD
phone: +8615105165989
email: cencen_njjs@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Ruihua Shi
investigator title: MD, PhD, Postdoctoral Mentor, Chief Physician
mesh term: Esomeprazole
mesh term: Mosapride
sharing ipd: Undecided