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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).
Full description
Inclusion/Exclusion criteria: Inclusion:
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
Study groups:
Patients recruited will be randomized to undergo antireflux mucosal ablation (ARAT) OR sham intervention after inclusion and exclusion criteria have been met.
Study procedure:
Patients will be randomized (1:1) to one of the arms by computer generated random sequence of numbers.
The following study visits are foreseen for each patient:
Screening Visit(s) A screening visit is performed at the investigational site. During this visit out-patients will be informed about the aims, procedures, benefits and possible risks of the study prior to signing the informed consent form for inclusion in the study. Their medical history will be recorded as well as eventual clinical or laboratory examinations according to the local standard of care preparation for an upper endoscopy.
Randomization (Intervention) visit: Each eligible patient returns to the clinic to undergo either the study intervention OR sham intervention.
24-48 hour and 7-10 day post randomization phone call for adverse events among both groups.
25-30 day post randomization phone call for adverse events among both groups.
3-4 Month (80-112 days post randomization) visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
6-7 month (165-196 days post randomization) visit phone call to include administration of the validated GERD-HRQL and RDQ questionnaires
11-12 month (336-365 days post randomization) visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
Secondary aims:
erosive esophagitis, and placement of pH capsule. During the 3 month, 6 month and 12 months visit, use of PPI therapy (dose and frequency) will be recorded. Response to therapy will be assessed using the following parameters: improvement of GERD-HRQL scores, reduction in RDQ scores, AET <4% and DeMeester score <14 (off PPI). Any patients with dysphagia after the ARAT will undergo repeat endoscopy for evaluation. If significant stricture, endoscopic dilation will be performed per severity of symptoms and stenosis.
Duration of this study from subject randomization to completion is 1 year, however, we anticipate study duration of at least 24 months for subject screening, completion of study visits and data analysis.
Enrollment
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Inclusion criteria
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 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
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups, including a placebo group
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Central trial contact
Rajesh Goud Dr Maragoni, Bpharm, Mpharm, MBA, PGDM; Rakesh Dr Kalapala, MBBS MD DNB
Data sourced from clinicaltrials.gov
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