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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Intervention / Treatment
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* Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)
* Drug: Esomeprazole + Mosapride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 16 to 80 years old Full sufficiency in literacy Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis Exclusion Criteria: Severe heart, lung, and cerebrovascular disease Severe hematopoietic system disease Abnormal blood coagulation function Oropharyngeal abnormalities Severe spine malformation In pregnancy and lactation at present, or plan to become pregnant within 2 years Severe inflammation or huge ulcers in stomach Mental and psychological disorder

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-POEM<br>Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM). | Procedure: Gastric peroral endoscopic pyloromyotomy (G-POEM)<br>* 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.<br>* Other names: Peroral endoscopic pyloromyotomy (POP);|
| Active Comparator: Esomeprazole + Mosapride<br>Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid. | Drug: Esomeprazole + Mosapride<br>* Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.<br>* Other names: Nexium + Mosapride Citrate Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Gastric Emptying Imaging at 6 months. | Each participant will receive gastric emptying imaging measurement both at baseline and 6 months. | From baseline to 6 months. | 
| Change from Baseline in Gastric Emptying Imaging at 12 months. | Each participant will receive gastric emptying imaging measurement both at baseline and 12 months. | From baseline to 12 months. | 
| Change from Baseline in Gastric Emptying Imaging at 24 months. | Each participant will receive gastric emptying imaging measurement both at baseline and 24 months. | From baseline to 24 months. | 
| Change from Baseline in Gastric Antrum Volume at 6 months. | Each participant will receive gastric antrum volume measurement both at baseline and 6 months. | From baseline to 6 months. | 
| Change from Baseline in Gastric Antrum Volume at 12 months. | Each participant will receive gastric antrum volume measurement both at baseline and 12 months. | From baseline to 12 months. | 
| Change from Baseline in Gastric Antrum Volume at 24 months. | Each participant will receive gastric antrum volume measurement both at baseline and 24 months. | From baseline to 24 months. | 
| Change from Baseline in Gastric Emptying Time at 6 months. | Each participant will receive gastric emptying time measurement both at baseline and 6 months. | From baseline to 6 months. | 
| Change from Baseline in Gastric Emptying Time at 12 months. | Each participant will receive gastric emptying time measurement both at baseline and 12 months. | From baseline to 12 months. | 
| Change from Baseline in Gastric Emptying Time at 24 months. | Each participant will receive gastric emptying time measurement both at baseline and 24 months. | From baseline to 24 months. | 
| Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months. | Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months. | From baseline to 6 months. | 
| Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months. | Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months. | From baseline to 12 months. | 
| Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months. | Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months. | From baseline to 24 months. | 
| Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months. | Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months. | From baseline to 6 months. | 
| Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months. | Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months. | From baseline to 12 months. | 
| Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months. | Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months. | From baseline to 24 months. |