Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

Not Applicable

Recruiting

• Conditions: Gastro Esophageal Reflux
• Interventions: Procedure: Sham intervention (control); Procedure: ARAT

• Registration Number: NCT05570448
• Lead Sponsor: Midwest Veterans' Biomedical Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-09-29
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No treatment	Sham intervention (control)	no ablation
Anti-reflux mucosal ablation (ARAT)	ARAT	ablation in the gastric cardia using hybrid argon plasma coagulation

Primary Outcome Measures

Name	Time	Method
Change in GERD health related quality of life (GERD-HRQL) score	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 Outcome Measures

Name	Time	Method
Acid exposure time (AET)	At 3 and 12 months	Ambulatory acid reflux testing (wireless pH monitoring system) for measurement. Acid exposure time measures amount of time spent in pH \<4. A time \>4% is considered positive for acid reflux.
Esophagitis incidence	At 3 and 12 months	LA grade esophagitis at the time of endoscopy
Change in Reflux disease questionnaire (RDQ) score	At 3, 6 and 12 months	RDQ scores will be assessed using a validated questionnaire scale. The total score is 40, and a higher score is associated with more severe symptoms.
Change in Proton pump inhibitor (PPI) use	At 3, 6 and 12 months	Frequency of PPI medication use
Adverse events	Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)	Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization
Change in Hiatal hernia grading	At 3 and 12 months	Hill grade for hiatal hernia assessment during endoscopy. There are 4 grades: I, II, III and IV depending on the appearance of the hiatus on endoscopy.

Trial Locations

Locations (1)

Kansas City VA Hospital; 🇺🇸 Kansas City, Missouri, United States