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临床试验/NCT02018705
NCT02018705终止不适用

Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study

Universitätsklinikum Hamburg-Eppendorf5 个研究点 分布在 4 个国家目标入组 47 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
47
试验地点
5
主要终点
treatment success

研究概览

简要总结

For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, long-term comparative data with LHM is required. Therefore,the intention for this study is to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

详细描述

Achalasia is a neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. The standard surgical treatment for achalasia is laparoscopic Heller Myotomy (LHM). A recent meta-analysis of 105 studies reporting on 7855 patients demonstrated that laparoscopic Heller myotomy is the most effective and long-lasting therapy for achalasia. Superior to Endoscopic balloon dilatation or Botulinumtoxin injection LHM has a one year therapeutic efficacy in approximately 90% of patients. Recently an endoscopic technique emulating the principles of LHM was developed. This technique of a purely endoscopic myotomy has been demonstrated by Pasricha et al. in animal experiments and Inoue et al. reported the first clinical study. Other pilot studies and a larger international multi-center trial have replicated promising results for POEM.

Uncontrolled studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, however, comparative data with LHM is required. Our study group intends to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 with symptomatic achalasia and pre-op barium swallow, manometry and oesophago-gastro-duodenoscopy which have been consistent with the diagnosis
  • Age > 18 years with medical indication for interventional achalasia treatment
  • Availability of Eckardt score at baseline and 12 months after initial treatment

排除标准

  • Patients with previous surgery of the stomach or esophagus
  • Patients with known coagulopathy
  • Previous surgical achalasia treatment
  • Patients with liver cirrhosis and/or esophageal varices
  • Active esophagitis
  • Eosinophilic esophagitis
  • Barrett's esophagus
  • Stricture of the esophagus
  • Malignant or premalignant esophageal lesion
  • Severe Candida esophagitis
  • Hiatal hernia > 1cm
  • Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus

结局指标

主要结局

treatment success

时间窗: 1 year after treatment

treatment success is defined as an Eckardt Score \</=3

次要结局

  • lower esophageal sphincter pressure (LESP)(12 months after treatment)
  • procedure related adverse events(12 months after treatment)
  • symptomatic reflux and use of antacid medication(12 months after treatment)

研究者

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

Prof. Dr. Thomas Rösch

Medical Director, Interdisciplinary Endoscopy Department and Clinic

Universitätsklinikum Hamburg-Eppendorf

研究点 (5)

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