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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: ARMA (antireflux ablation of the cardiac mucosa); Procedure: upper digestive endoscopy

• Registration Number: NCT04711655
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-03-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-07
• Study Completion: 2025-02-07
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(ARMA) antireflux ablation of the cardiac mucosa	ARMA (antireflux ablation of the cardiac mucosa)	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	upper digestive endoscopy	Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital de San Agustín; 🇪🇸 Avilés, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital de Cabueñes; 🇪🇸 Gijón, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Rio Hortega; 🇪🇸 Valladolid, Spain

Hospital Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain