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)

NCT06641375 | Recruiting DMC

• 1 other identifier: AREA21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• AREA

  To determine if procedure can decrease Gastroesophageal reflux scores (RDQ) 50% compared to sham intervention at 3, 6 and 12 months

  1 year

Secondary Outcomes (4)

• Anti reflux ablation theraphy

  365 days

• AREA

  1 year

• Anti reflux ablation theraphy

  1 year

• Reflux disease

  1 year

Study Arms (2)

Anti reflux endoscopic theraphy using Argon plasma coagulation in GERD

ACTIVE COMPARATOR

To 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.

Device: Anti reflux endoscopic theraphy

Endoscopy

PLACEBO COMPARATOR

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.

Other: Endoscopy

Interventions

Anti reflux endoscopic theraphy DEVICE

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.

Anti reflux endoscopic theraphy using Argon plasma coagulation in GERD

Endoscopy OTHER

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.

Endoscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 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 and
• Objective evidence of reflux disease (positive ambulatory pH study)
• Patients prescribed standard dose of PPI for symptoms of GERD
• Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohan Dr Ramchandani, MBBS MD

  Asian institute of Gastroenterology/AIG Hospitals

  PRINCIPAL INVESTIGATOR

• Kriti Dr Krishna, MBBS MD

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Dr Kalapala, MBBS MD DNB

CONTACT

04023378888; drrakesh.kalapala@aighospitals.com

Rajesh Goud Dr Maragoni, Bpharm, Mpharm, MBA, PGDM

CONTACT

04023378888; rajeshgoud761@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: STUDY DIRECTOR

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: February 10, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 10, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)