Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Percentage of patients with clinically significant perforation
研究概览
简要总结
Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.
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
- •Patients of both sexes aged over 18 years old
- •Patients who have signed the informed consent form before any study related procedure
- •Primary achalasia of the cardia with Eckardt score > 3
- •Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study
- •ASA score (American Society of Anaesthesiologists) 1 or 2
- •Patients affiliated to a social security health system
排除标准
- •Patients with age less than 18 years old
- •Patients without discernment with legal protection
- •Patients who will not be able to abide with study follow-up as judged by the investigator
- •Patients which cannot provide a written informed consent
- •Patient refusing to participate in the study, without informed consent
- •Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
- •Concomitant participation in other clinical trial
- •S2 sigmoid type primitive achalasia of the cardia
- •Pseudo-achalasia (esophageal carcinoma),
- •History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
- •History of esophageal strictures, systemic sclerosis
- •History of esophageal varices
- •History of endoscopic or surgical therapy of the esophageal achalasia
- •History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
- •History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)
- •History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP < 60%, TCA > 40 seconds, platelets < 60000/mmc)
- •ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6
- •Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.
结局指标
主要结局
Percentage of patients with clinically significant perforation
时间窗: Day 1 after procedure
Clinically significant perforation is defined as an ensemble of procedural, clinical, biological and imaging parameters: * perforation seen during procedure with placement of endoscopic metallic clips as closing method * acute severe persistent pain, fever over 38.5°C, subcutaneous emphysema, pneumomediastinum, penumoperitoneum * elevated white blood count with elevated neutrophils and elevated CRP, ascending values * subcutaneous emphysema, pneumomediastinum, penumoperitoneum seen at imaging studies (day 1 CT scan)
次要结局
- significant variation of Eckardt score(at baseline and at 1st, 3rd, 6th and 12th month after the procedure)
- significant variation of GIQLI score(at baseline and at 1st, 3rd, 6th and 12th month after the procedure)
- percentage of patients with Eckardt score less than 3(at 3rd and 12th month after procedure)
- significant variation of high resolution manometry parameters(at baseline and at 3rd month after the procedure)