the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- GERD-HRQL scores
研究概览
简要总结
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
详细描述
Gastro-esophageal reflux disease (GERD) is the most common outpatient diagnosis in gastroenterology and is associated with a significant burden on the healthcare system. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment,howerver, some patients have an unsatisfactory response to high doses of PPIs, which remains a challenge. The Stretta procedure, a radiofrequency (RF) application to the lower esophageal sphincter (LES), was introduced about 15 years ago as an alternative to chronic medical therapy or surgical intervention for GERD.The Stretta procedure appears to result in thickening of the LES, decreased transient LES relaxation rate and reduced esophageal acid exposure.The majority studies of Stretta were held in USA and Europe, the sduty of Stretta in Asia is rare. The investigators propose to perform a prospectively observiton study to evaluate the efficency of the Stretta procedure in patients of refractory GERD in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Small hiatus hernia (< 2-3 cm)
- •Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis
- •LES pressure <15 mm Hg
- •PPI dependent / refractory GERD
- •abnormal 24h esophagus pH-impedance monitoring
排除标准
- •Age < 18 years
- •Large hiatus hernia (> 3 cm)
- •Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- •LES pressure > 15 mm Hg
- •Underlying coagulation disorder
- •Previous Esophageal or Gastric surgery
- •major esophagus motility disorder according to Chicago v3.0
结局指标
主要结局
GERD-HRQL scores
时间窗: [Time Frame: Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year]
the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy.
次要结局
- LES Pressure(1 year)
- Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure(Change from Baseline number at 1 month;Change from Baseline number at 2 months;Change from Baseline number at 6 months;Change from Baseline number at 1 year])
- Demeester Score(1 year)
- Number of participants with treatment-related adverse events(1 month)
研究者
Guo Zihao
Clinical Professor
Capital Medical University