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| Name | Class |
|---|---|
| Spanish Society of Digestive Endoscopy | OTHER |
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The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (ARMA) antireflux ablation of the cardiac mucosa | Experimental | The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm. |
|
| upper digestive endoscopy | Placebo Comparator | Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARMA (antireflux ablation of the cardiac mucosa) | Procedure | is an endoscopy in which argon gas ablation of the cardiac mucosa |
|
| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique MD Rodríguez de Santiago | Servicio de Gastroenterología y Hepatología Hospital Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de San Agustín | Avilés | Spain | ||||
| Hospital Germans Trias I Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41475422 | Derived | Rodriguez de Santiago E, Teruel Sanchez-Vegazo C, Albeniz E, Estremera Arevalo F, Arrubla Gamboa A, Castel I, Arribas Anta J, Marin-Gabriel JC, Diez Redondo P, Nunez Rodriguez H, Herreros De Tejada A, El Hajra Martinez I, Riu Pons F, Naves JE, Uchima H, Marin I, Duque Alcorta JM, Perez Corte D, De Maria Pallares P, Perez Enciso I, Garcia Suarez C, Lorenzo-Zuniga V, Nogales O, Muriel A, Albillos A; ECA-ARMA authors of the Mucosal Resection and Third-Space Endoscopy SEED Working Group. Multicenter, double-blind, sham endoscopy-controlled, randomized trial evaluating the efficacy of antireflux mucosal ablation for the treatment of gastroesophageal reflux disease. Endoscopy. 2026 Jun;58(6):595-607. doi: 10.1055/a-2780-0706. Epub 2025 Dec 31. |
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| upper digestive endoscopy | Procedure | Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm. |
|
| 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 |
| 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 |
| Badalona |
| Spain |
| Hospital Del Mar | Barcelona | Spain |
| Hospital de Cabueñes | Gijón | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Rio Hortega | Valladolid | Spain |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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