Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical success rates
研究概览
简要总结
POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years
- •Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
- •Signed written informed consent
排除标准
- •ASA class > Ⅲ
- •Previous endoscopic or surgical treatment for achalasia
- •Esophageal malignancy
研究组 & 干预措施
snare group
snare-assisted POEM
干预措施: snare-assisted POEM (Device)
conventional group
knife-assisted POEM
干预措施: knife-assisted POEM (Device)
结局指标
主要结局
Clinical success rates
时间窗: 12 months after treatment
Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
次要结局
- Procedure-related adverse events(baseline to 12 months after treatment)
- Procedure time(POEM procedure)
- Gastroesophageal reflux disease questionnaire (GerdQ) score(baseline, 3 months and 12 months after treatment)
- The volume of intraoperative bleeding(POEM procedure)
- Postoperative pain requiring the use of tramadol(Through hospital stay after procedure, an average of 2-7 days)
- The use of hemostatic forceps(POEM procedure)
- Total hospital costs of treatment per participants(Through hospital stay after procedure, an average of 2-7 days)
- The length of postoperative hospital stay(Through hospital stay after procedure, an average of 2-7 daysc)
- Eckardt score(baseline, 3 months and 12 months after treatment)
- Manometry parameters(baseline and 3 months after treatment)
- Reflux esophagitis on post-POEM endoscopy(3 months after treatment)
- Maximum esophageal diameter on barium esophagram(baseline and 3 months after treatment)
研究者
Xiangbin Xing
MD, PhD
First Affiliated Hospital, Sun Yat-Sen University