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临床试验/NCT02989883
NCT02989883Unknown不适用

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
number of patients with Eckardt score <3 after the procedure

研究概览

简要总结

Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.

详细描述

Prospective study

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were diagnosed as esophageal outflow obstruction
  • Patients with informed consent

排除标准

  • Diagnostic uncertainty
  • Patients who are not suitable for general anesthesia

结局指标

主要结局

number of patients with Eckardt score <3 after the procedure

时间窗: 1 month after the procedure

次要结局

  • adverse events which are related to the procedure(within 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hwoon-Yong Jung

Professor

Asan Medical Center

研究点 (1)

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