跳至主要内容
临床试验/ISRCTN74448884
ISRCTN74448884进行中(未招募)未知

Peroral endoscopic myotomy vs endoscopic balloon dilation for the treatment of achalasia in children

Amsterdam University Medical Centers0 个研究点目标入组 80 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
80

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

性别
All

入选标准

  • 1. Eckardt score >3
  • 2. Presence of a HRM pattern consistent with achalasia type I or II according to the Chicago classification (CC) V3.0 criteria
  • 3. Age 7 years up to 17 years inclusive

排除标准

  • 1. Achalasia type III (this extremely rare subtype in children that is accompanied by esophageal spasm and associated complaints has a worse prognosis compared to type I and II. Literature and expert-opinion based recommendations suggest to treat type III with POEM. Randomizing these patients to EBD with a high a priori risk of relapses is therefore considered unethical)
  • 2. Previous surgical or endoscopical achalasia treatment
  • 3. Previous surgery of the upper gastrointestinal tract
  • 4. Known coagulopathy
  • 5. Known Liver cirrhosis and/or esophageal varices
  • 6. Known LA grade =B esophagitis
  • 7. Known Barrett’s esophagus
  • 8. Known pregnancy at time of treatment
  • 9. Stricture of the esophagus
  • 10. Known presence of malignant or premalignant esophageal lesions
  • 11. Hiatal hernia >1 cm based on HRM measurement
  • 12. Extensive, tortuous dilatation (>7 cm luminal diameter, S shape) of the esophagus
  • 13. Barium esophagram suggestive of other pathologies

研究者

发起方
Amsterdam University Medical Centers

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