NCT03040817

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Interventions

Type	Name	Description
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.
DRUG	Esomeprazole + Mosapride	Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-08-16
• Completion: 2019-12-16
• First posted: 2017-02-02
• Last updated: 2017-08-29

Locations

1 site across 1 country: China