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

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)

Overview

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.

Interventions

• 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 w
• 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 Pat

Primary outcome measures

• Change in GERD health related quality of life (GERD-HRQL) score [Time frame: At 3, 6 and 12 months]

Secondary outcome measures (6)

• Change in Reflux disease questionnaire (RDQ) score [Time frame: At 3, 6 and 12 months]
• Change in Proton pump inhibitor (PPI) use [Time frame: At 3, 6 and 12 months]
• Acid exposure time (AET) [Time frame: At 3 and 12 months]
• Adverse events [Time frame: Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)]
• Change in Hiatal hernia grading [Time frame: At 3 and 12 months]
• Esophagitis incidence [Time frame: At 3 and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Kansas City VA Hospital — Kansas City

Publications

• Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8. PMID 9136821
• El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13. PMID 23853213
• Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005 Aug 2;143(3):199-211. doi: 10.7326/0003-4819-143-3-200508020-00006. PMID 16061918
• Yadlapati R, Vaezi MF, Vela MF, Spechler SJ, Shaheen NJ, Richter J, Lacy BE, Katzka D, Katz PO, Kahrilas PJ, Gyawali PC, Gerson L, Fass R, Castell DO, Craft J, Hillman L, Pandolfino JE. Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel. Am J Gastroenterol. 2018 Jul;113(7):980-986. doi: 10.1038/s41395-018-0045-4. Epub 2 PMID 29686276
• Delshad SD, Almario CV, Chey WD, Spiegel BMR. Prevalence of Gastroesophageal Reflux Disease and Proton Pump Inhibitor-Refractory Symptoms. Gastroenterology. 2020 Apr;158(5):1250-1261.e2. doi: 10.1053/j.gastro.2019.12.014. Epub 2019 Dec 19. PMID 31866243
• Vaezi MF, Yang YX, Howden CW. Complications of Proton Pump Inhibitor Therapy. Gastroenterology. 2017 Jul;153(1):35-48. doi: 10.1053/j.gastro.2017.04.047. Epub 2017 May 19. PMID 28528705
• Maret-Ouda J, Wahlin K, El-Serag HB, Lagergren J. Association Between Laparoscopic Antireflux Surgery and Recurrence of Gastroesophageal Reflux. JAMA. 2017 Sep 12;318(10):939-946. doi: 10.1001/jama.2017.10981. PMID 28898377
• Witteman BP, Conchillo JM, Rinsma NF, Betzel B, Peeters A, Koek GH, Stassen LP, Bouvy ND. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31. PMID 25823768

Identifiers

NCT: NCT05570448 · PS0100 · 1650419

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗