Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
研究概览
简要总结
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
详细描述
This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.
Primary outcome:
-eckhardt symptom score 3 month after therapy.
Secondary outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Peroral Endoscopic Myotomy
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment
干预措施: Peroral Endoscopic Myotomy (Other)
结局指标
主要结局
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
时间窗: 3 months after treatment
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(\>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.
次要结局
- mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure(manometry at 3 month after therapy)
- Number of Participants With Reflux Symptoms(during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment)
- Number of Participants With Procedure-related Adverse Events(procedure to 3 months post procedure)
- Medication 3 Months After POEM(3 months)
- Duration Time Procedure(procedure)
- Days Duration Hospitalization(days of hospitalization for POEM procedure, an average of 4 days)
- cm Myotomy Length(POEM procedure)
- Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment(3 months after treatment)