Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- AREA
研究概览
简要总结
Background and Rationale:
Gastroesophageal reflux disease is affecting 1 in 3 US adults with half experiencing daily symptoms. Per recent data, more than 50% continue to experience daily symptoms despite taking medical therapy and not eligible for surgery. In that small fraction of patients who are eligible for surgery, more than 70% resume taking a medicine for their reflux disease. GERD is common among the US veterans and currently there is a lack of minimally invasive endoscopic therapies for management of GERD. This study will investigate performance of minimally invasive, endoscopic therapy using antireflux mucosal ablation (hybrid argon plasma coagulation) that has been used in other areas of GI tract with efficacy and safety for management of chronic GERD among the US veterans.
Objective:
The aim of this study is to assess the safety and effectiveness of antireflux mucosal ablation or ARAT (intervention group) in patients with chronic gastroesophageal reflux disease (GERD) symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months and objective evidence of reflux disease (positive ambulatory pH study off PPI for 5-7 days) compared to sham procedure (control group).
详细描述
Inclusion/Exclusion criteria: Inclusion:
- Patients with chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months and
- Objective evidence of reflux disease (positive ambulatory pH study)
- Patients prescribed standard dose of PPI for symptoms of GERD
- Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist.
Exclusion:
-
Patients unable to or unwilling to participate or consent
-
Age <18 years or >80 years
-
Allergic or intolerant to PPI medications
-
Large hiatal hernia > 3 cm and Hill grade IV
-
Barrett's esophagus
-
Esophageal stricture with any prior intervention
-
Major motility disorder on HRM
-
Eosinophilic esophagitis 8. Gastroparesis documented by abnormal gastric emptying time 9. Previous fundoplication, myotomy or LINX surgery 10. Cirrhosis with esophageal and/or gastric varices
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months and
- •Objective evidence of reflux disease (positive ambulatory pH study)
- •Patients prescribed standard dose of PPI for symptoms of GERD
- •Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist.
排除标准
- •Patients unable to or unwilling to participate or consent
- •Age <18 years or >80 years
- •Allergic or intolerant to PPI medications
- •Large hiatal hernia > 3 cm and Hill grade IV
- •Barrett's esophagus
- •Esophageal stricture with any prior intervention
- •Major motility disorder on HRM
- •Eosinophilic esophagitis
- •Gastroparesis documented by abnormal gastric emptying time
- •Previous fundoplication, myotomy or LINX surgery
- •Cirrhosis with esophageal and/or gastric varices
结局指标
主要结局
AREA
时间窗: 1 year
To determine if procedure can decrease Gastroesophageal reflux scores (RDQ) 50% compared to sham intervention at 3, 6 and 12 months
次要结局
- Anti reflux ablation theraphy(1 year)
- AREA(1 year)
- Reflux disease(1 year)
研究者
Mohan Ramchandani
STUDY DIRECTOR
Asian Institute of Gastroenterology, India