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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

ARMA (antireflux ablation of the cardiac mucosa)PROCEDURE

is an endoscopy in which argon gas ablation of the cardiac mucosa

upper digestive endoscopyPROCEDURE

Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Hospital de San Agustín

Avilés, Spain

Hospital Germans Trias I Pujol

Badalona, Spain

Hospital Del Mar

Barcelona, Spain

Hospital de Cabueñes

Gijón, Spain

Outcomes

Primary Outcomes

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.

Time frame: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

Secondary Outcomes

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%;

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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