Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in GERD health related quality of life (GERD-HRQL) score
研究概览
简要总结
This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months.
Patients must have a positive pH test and a negative manometry (no treatment) procedure.
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
- Double (Participant, Care Provider)
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
- •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
- •Objective evidence of reflux disease (positive ambulatory pH study.)
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.
- •Eosinophilic esophagitis.
- •Gastroparesis documented by abnormal gastric emptying time.
- •Previous fundoplication, myotomy or LINX surgery.
- •Cirrhosis with esophageal and/or gastric varices.
研究组 & 干预措施
Anti-reflux mucosal ablation (ARAT)
ablation in the gastric cardia using hybrid argon plasma coagulation
干预措施: ARAT (Procedure)
No treatment
no ablation
干预措施: Sham intervention (control) (Procedure)
结局指标
主要结局
Change in GERD health related quality of life (GERD-HRQL) score
时间窗: At 3, 6 and 12 months
The primary outcome of quality of life will be measured using the validated GERD related quality of life questionnaire (GERD-HRQL). The total score is 50, and a higher score is associated with more severe symptoms.
次要结局
- Acid exposure time (AET)(At 3 and 12 months)
- Esophagitis incidence(At 3 and 12 months)
- Change in Reflux disease questionnaire (RDQ) score(At 3, 6 and 12 months)
- Change in Proton pump inhibitor (PPI) use(At 3, 6 and 12 months)
- Adverse events(Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month))
- Change in Hiatal hernia grading(At 3 and 12 months)