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Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040817
Recruitment Status : Unknown
Verified August 2017 by Ruihua Shi, Zhongda Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ruihua Shi, Zhongda Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM) Drug: Esomeprazole + Mosapride Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 16, 2019
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: G-POEM
Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).
Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)

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.

Other Name: Peroral endoscopic pyloromyotomy (POP)

Active Comparator: Esomeprazole + Mosapride
Each participant receive Esomeprazole+ Mosapride. The dosages are:Nexium 40mg bid, Mosapride Citrate Tablets 5mg tid.
Drug: Esomeprazole + Mosapride
Each participant receive Esomeprazole (Nexium) 40mg bid + Mosapride (Mosapride Citrate Tablets) 5mg tid.
Other Name: Nexium + Mosapride Citrate Tablets




Primary Outcome Measures :
  1. Change from Baseline in Gastric Emptying Imaging at 6 months. [ Time Frame: From baseline to 6 months. ]
    Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.

  2. Change from Baseline in Gastric Emptying Imaging at 12 months. [ Time Frame: From baseline to 12 months. ]
    Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.

  3. Change from Baseline in Gastric Emptying Imaging at 24 months. [ Time Frame: From baseline to 24 months. ]
    Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.

  4. Change from Baseline in Gastric Antrum Volume at 6 months. [ Time Frame: From baseline to 6 months. ]
    Each participant will receive gastric antrum volume measurement both at baseline and 6 months.

  5. Change from Baseline in Gastric Antrum Volume at 12 months. [ Time Frame: From baseline to 12 months. ]
    Each participant will receive gastric antrum volume measurement both at baseline and 12 months.

  6. Change from Baseline in Gastric Antrum Volume at 24 months. [ Time Frame: From baseline to 24 months. ]
    Each participant will receive gastric antrum volume measurement both at baseline and 24 months.

  7. Change from Baseline in Gastric Emptying Time at 6 months. [ Time Frame: From baseline to 6 months. ]
    Each participant will receive gastric emptying time measurement both at baseline and 6 months.

  8. Change from Baseline in Gastric Emptying Time at 12 months. [ Time Frame: From baseline to 12 months. ]
    Each participant will receive gastric emptying time measurement both at baseline and 12 months.

  9. Change from Baseline in Gastric Emptying Time at 24 months. [ Time Frame: From baseline to 24 months. ]
    Each participant will receive gastric emptying time measurement both at baseline and 24 months.

  10. Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months. [ Time Frame: From baseline to 6 months. ]
    Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.

  11. Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months. [ Time Frame: From baseline to 12 months. ]
    Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.

  12. Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months. [ Time Frame: From baseline to 24 months. ]
    Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.

  13. Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months. [ Time Frame: From baseline to 6 months. ]
    Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.

  14. Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months. [ Time Frame: From baseline to 12 months. ]
    Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.

  15. Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months. [ Time Frame: From baseline to 24 months. ]
    Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 16 to 80 years old
  2. Full sufficiency in literacy
  3. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
  4. Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis

Exclusion Criteria:

  1. Severe heart, lung, and cerebrovascular disease
  2. Severe hematopoietic system disease
  3. Abnormal blood coagulation function
  4. Oropharyngeal abnormalities
  5. Severe spine malformation
  6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
  7. Severe inflammation or huge ulcers in stomach
  8. Mental and psychological disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040817


Contacts
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Contact: Ruihua Shi, MD,PhD +8613951799326 ruihuashi@126.com
Contact: Jiacheng Tan, MD,PhD +8615105165989 cencen_njjs@126.com

Locations
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China, Jiangsu
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China
Contact: Ruihua Shi       ruihuashi@126.com   
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Study Chair: Huiping Wang Zhongda Hospital Southeast University
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Responsible Party: Ruihua Shi, MD, PhD, Postdoctoral Mentor, Chief Physician, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT03040817    
Other Study ID Numbers: GI of ZhongdaH
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Esomeprazole
Mosapride
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs