Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With Refractory Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs
研究概览
简要总结
Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising results in these patients. The investigators aims are to evaluate security and efficacy of this endoscopic treatment in participants with refractory gastroparesis.
详细描述
Gastroparesis is a chronic, condition characterized by a delayed gastric emptying without a mechanical obstruction. This disease is associated with high morbidity and mortality with a prevalence up to 4% of population. Patients with this disease have a reduced quality of life. The principal etiologies include: post-surgical, diabetes, medications and idiopathic. Symptoms include nausea, vomiting, early satiety, bloating and abdominal pain. Diagnosis is based on the combination of symptoms and studies as gastroscopy that shows retained food in the stomach without a gastric outlet obstruction and confirmed with a gastric emptying scintigraphy. Treatments have limited effect in these patients, including medications, botulinum toxin injection, surgical gastric electrical stimulation, laparoscopic pyloroplasty and stent placement. G-POEM is a new technique based on per-oral endoscopic myotomy treatment in achalasia patients, which has been recently proposed for treatment of patients with refractory gastroparesis with good initial results. The investigators aim is to evaluate the safety and efficacy of this new technique in a group of mexican participants with this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with refractory gastroparesis based on delayed gastric emptying symptoms: Nausea, retching, vomiting, abdominal pain, early satiety, post-prandial fullness, bloating.
- •Refractoriness defines as the presence of symptoms with failure or recurrence after other type of treatment.
- •Any etiology: diabetes, post-surgical, idiopathic
排除标准
- •Pregnancy
- •Portal hypertension
- •Gastric malignant condition
- •Active prepyloric ulcer
- •Mechanical pyloric stenosis
结局指标
主要结局
Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs
时间窗: 1, 6 and 12 months
The investigators will compare the percentage of improvement in scintigraphy before and after procedure
次要结局
- security of G-POEM in gastroparesis(up to 30 days after procedure)
