Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline GERD-HRQL scores at 12 months
研究概览
简要总结
This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.
详细描述
Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older
- •diagnosis of GERD established by either
- •24-h oesophageal pH monitoring (performed off medications) showing an abnormal OAE (pH < 4 at least 4% of time) and/or
- •an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los Angeles (LA) classification
- •presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy),
- •adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.
排除标准
- •presence of Barrett's oesophagus >3 cm and ⁄or with dysplasia and ⁄or previously treated,
- •presence of hiatus hernia >3 cm,
- •presence of oesophagitis grade C or D in LA classification,
- •presence of oesophageal stricture or achalasia,
- •history of oesophageal or gastric surgery,
- •presence of gastric or oesophageal varices,
- •impossibility to stop an anticoagulant therapy or severe coagulopathy,
- •any contraindication to general anaesthesia.
研究组 & 干预措施
Radiofrequency
Radiofrequency delivery to the gastroesophageal junction
干预措施: Radiofrequency delivery (Procedure)
结局指标
主要结局
Change from Baseline GERD-HRQL scores at 12 months
时间窗: 12 months
Assess the GERD-HRQL scores at 12 month and compare it with the baseline
次要结局
- Change from baseline lower esophageal sphincter pressure at 12 months(12 month)
- Change from baseline esophageal acid exposure times from at 12 months(12 month)
- Change from baseline esophagitis grade at 12 months(12 months)
- Change from baseline medication at 12 months(12 months)
研究者
Zhaoshen Li
Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
Changhai Hospital