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
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