Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.

Official Title
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Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: ARMA (antireflux ablation of the cardiac mucosa)
* Procedure: upper digestive endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation). Total acid exposure time> 6% in pH measurement study without PPI treatment. Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI. Written informed consent to participate in the study. Exclusion Criteria: Patients with sliding hiatal hernia> 2 cm. Presence of only atypical GERD symptoms. Age> 75 years. Grade D peptic esophagitis. Body mass index> 35 40 kg / m2. Liver cirrhosis. Pregnancy. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg). Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR. Esophagogastric surgery or previous endoscopic antireflux technique. Barrett's esophagus with dysplasia. Oncological disease. Esophageal strictures or ulcers. Severe cardiopulmonary comorbidity (ASA functional class IV-V). Previously known coagulopathy. Severe psychiatric disorder Refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (ARMA) antireflux ablation of the cardiac mucosa<br>The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm. | Procedure: ARMA (antireflux ablation of the cardiac mucosa)<br>* is an endoscopy in which argon gas ablation of the cardiac mucosa<br>|
| Placebo Comparator: upper digestive endoscopy<br>Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm. | Procedure: upper digestive endoscopy<br>* Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD. | GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL. | The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-Q questionnaire score | The GERDQ questionnaire is diagnostic for gastroesophageal reflux disease. Clinical success will be defined as a> 50% reduction in symptom score. The total Total score of 0 to 2 points = 0 % likelihood of GERD; 3 to 7 points = 50 %; 8 to 10 points = 79 %; 1 to 18 points = 89%; | The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12). | 
| PPI consumption | Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied. | It is measured in the different visits after the intervention (month 1, month 3 and month 12) | 
| pHmetry-impedancemetry | Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is acid exposure time. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 
| pHmetry-impedancemetry | Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is DeMeester score. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 
| pHmetry-impedancemetry | Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is reflux number. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 
| pHmetry-impedancemetry | Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is PSPW index. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 
| pHmetry-impedancemetry | Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is baseline impedance. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 
| High resolution manometry | This technique measures the pressure of esophageal contractions and with this technique different measurements are obtained such as lower esophageal sphincter resting pressure, integrated relaxation pressure, ICD. | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, argon gas, antireflux ablation of the cardiac mucosa (ARMA)