Gastroesophageal Reflux Disease
Conditions
Keywords
endoscopy, argon gas, antireflux ablation of the cardiac mucosa (ARMA)
Brief summary
The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects.
Detailed description
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.
Interventions
PROCEDUREARMA (antireflux ablation of the cardiac mucosa)
is an endoscopy in which argon gas ablation of the cardiac mucosa
PROCEDUREupper digestive endoscopy
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
Sponsors
Spanish Society of Digestive Endoscopy
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years. 2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation). 3. Total acid exposure time\> 6% in pH measurement study without PPI treatment. 4. 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. 5. Response to PPI treatment, defined as an increase of\> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI. 6. Written informed consent to participate in the study.
Exclusion criteria
1. Patients with sliding hiatal hernia\> 2 cm. 2. Presence of only atypical GERD symptoms. 3. Age\> 75 years. 4. Grade D peptic esophagitis. 5. Body mass index\> 35 40 kg / m2. 6. Liver cirrhosis. 7. Pregnancy. 8. Incomplete relaxation of the LES in MAR (PIR\> 15 mmHg). 9. Absent peristalsis, defined as 100% failed waves with DCI \<100 mmHg \* cm \* s in MAR. 10. Esophagogastric surgery or previous endoscopic antireflux technique. 11. Barrett's esophagus with dysplasia. 12. Oncological disease. 13. Esophageal strictures or ulcers. 14. Severe cardiopulmonary comorbidity (ASA functional class IV-V). 15. Previously known coagulopathy. 16. Severe psychiatric disorder 17. Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD. | The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GERD-Q questionnaire score | The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12). | 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%; |
| PPI consumption | It is measured in the different visits after the intervention (month 1, month 3 and month 12) | Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied. |
| pHmetry-impedancemetry | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 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. |
| High resolution manometry | This test will be performed on the patient before the intervention, in month 3 and in month 12 | 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. |
Countries
Spain
Outcome results
None listed