Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Gastric Emptying Imaging at 6 months.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
G-POEM
Each participant receive gastric peroral endoscopic pyloromyotomy (G-POEM).
干预措施: Gastric peroral endoscopic pyloromyotomy (G-POEM) (Procedure)
Esomeprazole + Mosapride
Each participant receive Esomeprazole+ Mosapride. The dosages are：Nexium 40mg bid， Mosapride Citrate Tablets 5mg tid.
干预措施: Esomeprazole + Mosapride (Drug)
结局指标
主要结局
Change from Baseline in Gastric Emptying Imaging at 6 months.
时间窗: From baseline to 6 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 6 months.
Change from Baseline in Gastric Emptying Time at 6 months.
时间窗: From baseline to 6 months.
Each participant will receive gastric emptying time measurement both at baseline and 6 months.
Change from Baseline in Gastric Antrum Volume at 6 months.
时间窗: From baseline to 6 months.
Each participant will receive gastric antrum volume measurement both at baseline and 6 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 12 months.
时间窗: From baseline to 12 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 12 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 6 months.
时间窗: From baseline to 6 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 6 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 24 months.
时间窗: From baseline to 24 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 24 months.
Change from Baseline in Gastric Emptying Imaging at 12 months.
时间窗: From baseline to 12 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 12 months.
Change from Baseline in Gastric Emptying Imaging at 24 months.
时间窗: From baseline to 24 months.
Each participant will receive gastric emptying imaging measurement both at baseline and 24 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 6 months.
时间窗: From baseline to 6 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 6 months.
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire at 12 months.
时间窗: From baseline to 12 months.
Each participant will receive gastroesophageal reflux disease questionnaire evaluation both at baseline and 12 months.
Change from Baseline in Gastric Emptying Time at 24 months.
时间窗: From baseline to 24 months.
Each participant will receive gastric emptying time measurement both at baseline and 24 months.
Change from Baseline in Gastric Antrum Volume at 12 months.
时间窗: From baseline to 12 months.
Each participant will receive gastric antrum volume measurement both at baseline and 12 months.
Change from Baseline in Gastric Antrum Volume at 24 months.
时间窗: From baseline to 24 months.
Each participant will receive gastric antrum volume measurement both at baseline and 24 months.
Change from Baseline in Gastric Emptying Time at 12 months.
时间窗: From baseline to 12 months.
Each participant will receive gastric emptying time measurement both at baseline and 12 months.
Change from Baseline in Gastroparesis Cardinal Symptoms Index at 24 months.
时间窗: From baseline to 24 months.
Each participant will receive gastroparesis cardinal symptoms index evaluation both at baseline and 24 months.
次要结局
未报告次要终点
研究者
Ruihua Shi
MD, PhD, Postdoctoral Mentor, Chief Physician
Zhongda Hospital