Gastro Esophageal Reflux
Conditions
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.
Interventions
PROCEDUREARAT
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.
PROCEDURESham 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.
Sponsors
Midwest Veterans' Biomedical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in Proton pump inhibitor (PPI) use | At 3, 6 and 12 months | Frequency of PPI medication use |
| 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. |
| Adverse events | Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month) | Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization |
| 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. |
| Esophagitis incidence | At 3 and 12 months | LA grade esophagitis at the time of endoscopy |
Countries
United States
Contacts
CONTACTApril Higbee, BSN
CONTACTCarlissa Campbell, MS
PRINCIPAL_INVESTIGATORPrateek Sharma, MD
Kansas City VA Hospital
STUDY_DIRECTORMadhav Desai, MD
Kansas City VA Hospital
Outcome results
None listed