Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Therapeutic success
研究概览
简要总结
This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
详细描述
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.
Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.
Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.
However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age;
- •Patient with esophageal achalasia;
- •Eckardt score > 3;
- •Signed informed consent.
排除标准
- •Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk;
- •Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus;
- •Previous endoscopic Botox injection;
- •Previous oesophageal or gastric surgery;
- •Pregnancy or lactation women, or ready to pregnant women;
- •Not capable of filling out questionnaires.
结局指标
主要结局
Therapeutic success
时间窗: From date of randomization until the follow-up ended, assessed up to 5 years
Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
次要结局
- Time of treatment failure(From date of randomization until the follow-up ended, assessed up to 5 years)
- Procedure related complication(From date of randomization until the follow-up ended, assessed up to 5 years)
- Pressure at the lower esophageal sphincter(From date of randomization until the follow-up ended, assessed up to 5 years)
- Quality of life(From date of randomization until the follow-up ended, assessed up to 5 years)
研究者
Wei Gong
Doctor of Medicine，Associate Professor
Nanfang Hospital, Southern Medical University