RecruitingNot ApplicableNCT05570448

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

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)

Sponsor

Midwest Veterans' Biomedical Research Foundation

Enrollment

36 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

Gastro Esophageal Reflux

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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 Criteria11

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.

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Interventions

PROCEDUREARAT

For patients randomized to ARAT intervention, the area of cardia, along greater curvature will be cleaned followed by demarcation of a 1-1.5 cm area of non-ablation zone with two vertical lines by use of Pulsed APC (30W, Effect 2) using the H-APC catheter. Next, the area of cardia, on either side will be injected in sequence using a methylene blue (0.5%) and normal saline (0.9%) using the H-APC catheter jet system (Effect 30-70). Next, the mucosa, starting below the z-line and up to 3 cm below will be treated by Pulsed APC 50W-80W till golden-brown discoloration of the ablated tissue in 270-320 degree. For patients randomized to control or sham intervention, upper endoscopy with procedural sedation was performed followed by markings of landmarks followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time. No H-APC or submucosal injection or other intervention will be performed.

PROCEDURESham intervention (control)

Patients randomized to the control arm, will undergo a sham intervention. This will include performing upper endoscopy with procedural sedation followed by markings of landmarks as described. This will be followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time spent in retroflexion to reciprocate the H-APC intervention. No H-APC or submucosal injection or other intervention will be performed during the upper endoscopy with sham intervention. All Patients will also continue their PPI daily for 4 weeks.