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 Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in GERD health related quality of life (GERD-HRQL) score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.)
Exclusion Criteria
- •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.
Arms & Interventions
Anti-reflux mucosal ablation (ARAT)
ablation in the gastric cardia using hybrid argon plasma coagulation
Intervention: ARAT (Procedure)
No treatment
no ablation
Intervention: Sham intervention (control) (Procedure)
Outcomes
Primary Outcomes
Change in GERD health related quality of life (GERD-HRQL) score
Time Frame: 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.
Secondary Outcomes
- 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)