跳至主要内容
临床试验/NL-OMON28707
NL-OMON28707招募中不适用

Anti-reflux mucosectomy (ARMS) for gastroesophageal reflux disease: efficacy and mechanism of action

Amsterdam UMC0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
11

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Indication for surgical treatment, defined by objectively confirmed gastroesophageal reflux disease (24-h ambulatory pH-impedance study with a symptom association probability =95%; and esophageal acid exposure =4%)
  • - Symptoms of heartburn, regurgitation and/or chest pain under PPI-treatment for at least 3 months at least 3 times a week.
  • - Use of proton pump inhibitors at a standard dose twice a day for at least 4 weeks prior to inclusion.

排除标准

  • - ASA classification of III or higher.
  • - Previous (surgical or endoscopic) anti-reflux procedure
  • - Previous surgery of the stomach or esophagus
  • - Sliding hiatal hernia >2cm
  • - Esophagitis grade C or D
  • - Presence of Barrett’s esophagus with dysplasia
  • - Known coagulopathy
  • - Unable to stop coagulants (with the exception of mono antiplatelet therapy)
  • - Presence of liver cirrhosis and/or esophageal varices
  • - Presence of a stricture of the esophagus
  • - Presence of eosinophilic esophagitis
  • - Presence of achalasia
  • - Presence of connective tissue disorder
  • - Absent peristalsis on high-resolution manometry
  • - Pregnancy at time of treatment

研究者

发起方
Amsterdam UMC

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