A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.
研究概览
简要总结
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
详细描述
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
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
- 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 > 18years
- •Small hiatus hernia (< 2-3 cm)
- •Los Angeles Grade 'A' or 'B' Reflux Esophagitis
- •LES pressure : 5 - 15 mm Hg
- •PPI dependent / refractory GERD
- •24 hr acid exposure study showing abnormal esophageal acid exposure > 4%
- •DeMeester Score >14.7
- •Esophageal manometry showing normal peristalsis
排除标准
- •Age < 18 years
- •Large hiatus hernia (> 3 cm)
- •Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- •LES pressure : < 5 or > 15 mm Hg
- •Underlying coagulation disorder
- •Previous Esophageal or Gastric surgery
- •H/o coronary artery disease (CAD)
- •Esophageal manometry showing ineffective peristalsis
结局指标
主要结局
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.
时间窗: 1 year
6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure \& Sham therapy amongst patients.
次要结局
- Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.(1 year)
- Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.(1 year)
研究者
Rakesh K
consultant gastroenterologist
Asian Institute of Gastroenterology, India