to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- efficacy of POEM treatment
研究概览
简要总结
Achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. Longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type Ⅱcases. Clinical observations also conclude that type Ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. Thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed of esophageal achalasia
- •Patients or legal surrogates willing and competent to give informed consent
排除标准
- •postoperative or post-POEM
- •post-pneumatic dilation or post-stenting
- •fail to go through high frequency intraluminal ultrasound （HFIUS)
- •Patients with American Society of Anesthesiologists （ASA） score ≥3
研究组 & 干预措施
POEM preserving longitudinal muscle
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
干预措施: POEM preserving longitudinal muscle (Procedure)
POEM involving longitudinal muscle
participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle
干预措施: POEM involving longitudinal muscle (Procedure)
结局指标
主要结局
efficacy of POEM treatment
时间窗: 4 weeks after POEM
Eckardt score ≤3; Eckardt scale includes 4 items: dysphagia, weight loss, poststernal pain and esophageal reflux, each item ranging from 0-3. The higher the score reaches, the more severe the disease is. It is considered to be efficient if the Eckardt score is ≤3 after POEM.
次要结局
- complications(GERD) of POEM treatment(4 weeks after POEM)