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 Cajal

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: upper digestive endoscopy; Procedure: ARMA (antireflux ablation of the cardiac mucosa)

Study type: Interventional

Funder types: Other

Identifiers

NCT04711655

ECA-HRC-ARMA

Details and patient eligibility

About

The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

(ARMA) antireflux ablation of the cardiac mucosa

Experimental group

Description:

The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm.

Treatment:

Procedure: ARMA (antireflux ablation of the cardiac mucosa)

upper digestive endoscopy

Placebo Comparator group

Description:

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

Treatment:

Procedure: upper digestive endoscopy