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)

Summary

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).

Conditions

• GERD

Interventions

DEVICE

Anti reflux endoscopic theraphy

o the intervention arm, the area of cardia, along greater curvature will be cleaned first followed by demarcation of a 1-1.5 cm area of non-ablation zone with two vertical lines by use of Pulsed APC using the H-APC catheter for marking and to prevent excess ablation . After this, the area of cardia, on either side will be injected in sequence using a combination of methylene blue and normal saline using the H-APC catheter jet system using between Effect 30 and Effect 70 on the ErbeJet 2 to raise the mucosa and create a submucosal cushion . Once adequate submucosal cushion is created, the mucosa starting below the z-line and up to 3 cm below will be treated by Pulsed APC 50W-80W using the H-APC catheter till golden-brown discoloration of the ablated tissue20 The area of cardia below the Z-line will be treated in a 270-320-degree fashion. Once adequate ablation is achieved and no deeper tissue injury or bleeding is ensured, the procedure will be terminated.

OTHER

Endoscopy

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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India

  lead OTHER

Principal Investigators

• Mohan Dr Ramchandani, MBBS MD · Asian institute of Gastroenterology/AIG Hospitals

• Kriti Dr Krishna, MBBS MD · AIG Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-10

Primary Completion

2025-02-01

Completion

2025-12-10

Countries

• India

Study Locations