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

NCT04711655 | Completed

• 1 other identifier: ECA-HRC-ARMA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease

Keywords

endoscopy; argon gas; antireflux ablation of the cardiac mucosa (ARMA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

• PPI consumption

  It is measured in the different visits after the intervention (month 1, month 3 and month 12)

• pHmetry-impedancemetry

  This test will be performed on the patient before the intervention, in month 3 and in month 12

• High resolution manometry

  This test will be performed on the patient before the intervention, in month 3 and in month 12

Study Arms (2)

(ARMA) antireflux ablation of the cardiac mucosa

EXPERIMENTAL

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

Procedure: ARMA (antireflux ablation of the cardiac mucosa)

upper digestive endoscopy

PLACEBO COMPARATOR

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

Procedure: upper digestive endoscopy

Interventions

ARMA (antireflux ablation of the cardiac mucosa) PROCEDURE

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

(ARMA) antireflux ablation of the cardiac mucosa

upper digestive endoscopy PROCEDURE

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

upper digestive endoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years.
• GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation).
• Total acid exposure time\> 6% in pH measurement study without PPI treatment.
• 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.
• Response to PPI treatment, defined as an increase of\> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI.
• Written informed consent to participate in the study.

You may not qualify if:

• Patients with sliding hiatal hernia\> 2 cm.
• Presence of only atypical GERD symptoms.
• Age\> 75 years.
• Grade D peptic esophagitis.
• Body mass index\> 35 40 kg / m2.
• Liver cirrhosis.
• Pregnancy.
• Incomplete relaxation of the LES in MAR (PIR\> 15 mmHg).
• Absent peristalsis, defined as 100% failed waves with DCI \<100 mmHg \* cm \* s in MAR.
• Esophagogastric surgery or previous endoscopic antireflux technique.
• Barrett's esophagus with dysplasia.
• Oncological disease.
• Esophageal strictures or ulcers.
• Severe cardiopulmonary comorbidity (ASA functional class IV-V).
• Previously known coagulopathy.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Spanish Society of Digestive Endoscopy: collaborator

Study Sites (9)

Hospital de San Agustín

Avilés, Spain

Location

Hospital Germans Trias I Pujol

Badalona, Spain

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital de Cabueñes

Gijón, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Rio Hortega

Valladolid, Spain

Location

Related Publications (1)

• Rodriguez de Santiago E, Teruel Sanchez-Vegazo C, Albeniz E, Estremera-Arevalo F, Arrubla Gamboa A, Castel de Lucas I, Arribas Anta J, Marin-Gabriel JC, Diez Redondo P, Nunez Rodriguez H, Herreros de Tejada A, El Haira Martinez I, Riu Pons F, Naves J, Uchima H, Marin I, Duque Alcorta JM, Perez Corte D, De Maria P, Perez Enciso I, Garcia-Suarez C, Lorenzo-Zuniga V, Nogales O, Muriel A, Albillos A. Multicenter, double-blind, sham endoscopy-controlled, randomized trial evaluating the efficacy of anti-reflux mucosal ablation for the treatment of gastro-esophageal reflux disease. Endoscopy. 2025 Dec 31. doi: 10.1055/a-2780-0706. Online ahead of print.

  PMID: 41475422 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Enrique MD Rodríguez de Santiago

  Servicio de Gastroenterología y Hepatología Hospital Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 15, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: February 7, 2025
• Last Updated: April 24, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)