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)
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: 1. Patients unable to or unwilling to participate or consent 2. Age \<18 years or \>80 years 3. Allergic or intolerant to PPI medications 4. Large hiatal hernia \> 3 cm and Hill grade IV 5. Barrett's esophagus 6. Esophageal stricture with any prior intervention 7. Major motility disorder on HRM 7\. 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