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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04711655
• Other study ID #: ECA-HRC-ARMA
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• ARMA (antireflux ablation of the cardiac mucosa)
is an endoscopy in which argon gas ablation of the cardiac mucosa
• upper digestive endoscopy
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

Locations

Country	Name	City	State
Spain	Hospital de San Agustín	Avilés
Spain	Hospital Germans Trias I Pujol	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

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Spanish Society of Digestive Endoscopy

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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 DeMeester score.	This test will be performed on the patient before the intervention, in month 3 and in month 12
Secondary	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 reflux number.	This test will be performed on the patient before the intervention, in month 3 and in month 12
Secondary	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 PSPW index.	This test will be performed on the patient before the intervention, in month 3 and in month 12
Secondary	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 baseline impedance.	This test will be performed on the patient before the intervention, in month 3 and in month 12
Secondary	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