Clinical trial NCT04711655: Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease
Official title: Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: endoscopy
argon gas
antireflux ablation of the cardiac mucosa (ARMA)
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Spanish Society of Digestive Endoscopy
First posted: 2021-01-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
timeFrame: 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:
measure: GERD-Q questionnaire score
timeFrame: The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
measure: PPI consumption
timeFrame: It is measured in the different visits after the intervention (month 1, month 3 and month 12)
measure: pHmetry-impedancemetry
timeFrame: This test will be performed on the patient before the intervention, in month 3 and in month 12
measure: High resolution manometry
timeFrame: This test will be performed on the patient before the intervention, in month 3 and in month 12
Other outcomes:
Locations:
city: Avilés
country: Spain
facility: Hospital de San Agustín
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
Study officials:
affiliation: Servicio de Gastroenterología y Hepatología Hospital Ramón y Cajal
name: Enrique MD Rodríguez de Santiago
role: PRINCIPAL_INVESTIGATOR
References: