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

Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)
Active Comparator: Anti-reflux mucosal ablation (ARAT)

ablation in the gastric cardia using hybrid argon plasma coagulation

Procedure: ARAT

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.

Other Name: Anti-reflux mucosal ablation

Source: View full study details on ClinicalTrials.gov

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October 7, 2022Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
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