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临床试验/NCT03126513
NCT03126513已完成不适用

Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With Refractory Gastroparesis

Coordinación de Investigación en Salud, Mexico2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年4月1日最近更新:
适应症

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

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)

研究者

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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