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临床试验/NCT01570621
NCT01570621Unknown4 期

Personalized Peroral Endoscopic Myotomy for Achalasia

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
1
主要终点
symptom relief

研究概览

简要总结

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
  • Age over 18 years old
  • Signed written informed consent

排除标准

  • Patients with previous surgery of the stomach or esophagus
  • With known coagulopathy
  • Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Hiatal hernia > 2cm

结局指标

主要结局

symptom relief

时间窗: 1-12months

compare patients' symptoms before and after POEM at 1 month, 12 months.

Lower esophageal sphincter pressure

时间窗: 1-12months

compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.

improvement of esophageal barium

时间窗: 1-12 months

compare esophageal barium before and after POEM at 1 months,12 months

Postoperative complications

时间窗: 0-12months

postoperative complications

次要结局

未报告次要终点

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zou Xiaoping

vice-principal

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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