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AREA21: Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

Sponsor
Midwest Veterans' Biomedical Research Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05570448
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
37.5
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ARAT
  • Procedure: Sham intervention (control)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Anti-reflux mucosal ablation

    		•
    Sham Comparator: No treatment

    no ablation

    Procedure: Sham 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Change in Proton pump inhibitor (PPI) use [At 3, 6 and 12 months]

      Frequency of PPI medication use

    3. 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.

    4. Adverse events [Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)]

      Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization

    5. 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.

    6. Esophagitis incidence [At 3 and 12 months]

      LA grade esophagitis at the time of endoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kansas City VA Hospital Kansas City Missouri United States 64128

    Sponsors and Collaborators

    • Midwest Veterans' Biomedical Research Foundation

    Investigators

    • Principal Investigator: Prateek Sharma, MD, Kansas City VA Hospital
    • Study Director: Madhav Desai, MD, Kansas City VA Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Midwest Veterans' Biomedical Research Foundation
    ClinicalTrials.gov Identifier:
    NCT05570448
    Other Study ID Numbers:
    • PS0100
    • 1650419
    First Posted:
    Oct 6, 2022
    Last Update Posted:
    Oct 6, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroesophageal Reflux

    Study Results

    No Results Posted as of Oct 6, 2022