Multicenter, triple-blind, sham endoscopy controlled clinical trial evaluating the efficacy of Anti-reflux Mucosal Ablation (ARMA) for the treatment of Gastroesophageal Reflux Disease (GERD)

E Rodriguez de Santiago; C Teruel Sanchez-Vegazo; A Herreros De Tejada; I Marín Fernández; M P Diez Redondo; M H Nuñez Rodriguez; M De Benito Sanch; H Uchima; D Burgos Santamaría; J M Duque Alcorta; D Perez Corte; E Albéniz; I Castel; F Estremera-Arevalo; J Arribas Anta; M Ramirez Verdyguer; F Riu Pons; J E Naves; P Beatriz; S Parejo; A Martínez Sánchez; P De Maria Pallares; I Perez Enciso; C García Suarez; M Pipa Muñiz; J C Marin-Gabriel; D de Frutos; J Santiago Garcia; V Matallana; V Lorenzo-Zúñiga; V Ortiz Bellber; A Arrubla; L Barranco Priego; A Muriel; L Del Campo Albendea; Ó Nogales Rincón; J García Lledó; I El Hajra Martínez; J Aranda Hernández; L Relea Pérez; E Vazquez Sequeiros; A Albillos Martínez

doi:10.1055/s-0045-1805133

Endoscopy, Inhaltsverzeichnis

Endoscopy 2025; 57(S 02): S23
DOI: 10.1055/s-0045-1805133

Abstracts | ESGE Days 2025

Oral presentation

GERD, EoE and so much more! 03/04/2025, 10:30 – 11:30 Room 120+121

Multicenter, triple-blind, sham endoscopy controlled clinical trial evaluating the efficacy of Anti-reflux Mucosal Ablation (ARMA) for the treatment of Gastroesophageal Reflux Disease (GERD)

Authors

E Rodriguez de Santiago

¹Ramón y Cajal Hospital, Madrid, Spain
C Teruel Sanchez-Vegazo

¹Ramón y Cajal Hospital, Madrid, Spain
A Herreros De Tejada

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
I Marín Fernández

³Hospital Germans Trias i Pujol, Badalona, Spain
M P Diez Redondo

⁴Rio Hortega University Hospital, Valladolid, Spain
M H Nuñez Rodriguez

⁴Rio Hortega University Hospital, Valladolid, Spain
M De Benito Sanch

⁴Rio Hortega University Hospital, Valladolid, Spain
H Uchima

³Hospital Germans Trias i Pujol, Badalona, Spain
D Burgos Santamaría

¹Ramón y Cajal Hospital, Madrid, Spain
J M Duque Alcorta

⁵Hospital Universitario San Agustín, Avilés, Aviles, Spain
D Perez Corte

⁵Hospital Universitario San Agustín, Avilés, Aviles, Spain
E Albéniz

⁶Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain
I Castel

⁷Hospital Universitario 12 de Octubre, Madrid, Spain
F Estremera-Arevalo

⁶Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain
J Arribas Anta

⁷Hospital Universitario 12 de Octubre, Madrid, Spain
M Ramirez Verdyguer

¹Ramón y Cajal Hospital, Madrid, Spain
F Riu Pons

⁸Hospital del Mar, Barcelona, Spain
J E Naves

⁸Hospital del Mar, Barcelona, Spain
P Beatriz

¹Ramón y Cajal Hospital, Madrid, Spain
S Parejo

¹Ramón y Cajal Hospital, Madrid, Spain
A Martínez Sánchez

¹Ramón y Cajal Hospital, Madrid, Spain
P De Maria Pallares

⁹La Paz University Hospital, Madrid, Spain
I Perez Enciso

⁹La Paz University Hospital, Madrid, Spain
C García Suarez

¹⁰Hospital de Cabueñes, Gijón, Spain
M Pipa Muñiz

¹⁰Hospital de Cabueñes, Gijón, Spain
J C Marin-Gabriel

⁷Hospital Universitario 12 de Octubre, Madrid, Spain
D de Frutos

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
J Santiago Garcia

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
V Matallana

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
V Lorenzo-Zúñiga

¹¹La Fe University and Polytechnic Hospital / IISLaFe, València, Spain
V Ortiz Bellber

¹²La Fe University and Polytechnic Hospital, València, Spain
A Arrubla

⁶Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain
L Barranco Priego

⁸Hospital del Mar, Barcelona, Spain
A Muriel

¹Ramón y Cajal Hospital, Madrid, Spain
L Del Campo Albendea

¹Ramón y Cajal Hospital, Madrid, Spain
Ó Nogales Rincón

¹³Gregorio Marañón General University Hospital, Madrid, Spain
J García Lledó

¹³Gregorio Marañón General University Hospital, Madrid, Spain
I El Hajra Martínez

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
J Aranda Hernández

¹³Gregorio Marañón General University Hospital, Madrid, Spain
L Relea Pérez

²Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain
E Vazquez Sequeiros

¹Ramón y Cajal Hospital, Madrid, Spain
A Albillos Martínez

¹Ramón y Cajal Hospital, Madrid, Spain

Abstract

Volltext

Aims Anti-reflux mucosal ablation (ARMA) has shown promising results for the treatment of gastroesophageal reflux disease (GERD) in observational studies. However, it has not been evaluated in clinical trials. Our primary objective was to assess its clinical efficacy and safety.

Methods Triple-blind (patient, clinical evaluator, and statistician), superiority, industry-independent, clinical trial conducted at 12 Spanish centers. Patients with chronic GERD (acid exposure time>6%) dependent on proton pump inhibitors (PPI) were included (increase>10 points in GERD-HRQL questionnaire upon PPI withdrawal). Patients with a hiatal hernia>2 cm were excluded. Patients were randomized (1:1) to ARMA with argon gas or sham endoscopy. The primary endpoint was clinical success, defined as a reduction of>50% in the GERD-HRQL score. pH-impedance and high-resolution manometry variables were evaluated. The main analysis was a modified intention-to-treat (mITT) analysis, which included randomized patients without protocol violations. Final results are presented at 3 months. ClinicalTrials.gov ID: NCT04711655.

Results A total of 63 patients were randomized, with 3 excluded during the monitoring phase for not meeting selection criteria. The mITT analysis included 31 patients in the ARMA group and 29 in the sham endoscopy group, with similar baseline characteristics. Clinical success at 3 months was similar in both groups: ARMA 61.3% (19/31) vs. sham endoscopy 51.7% (15/29), p=0.46. No clinically or statistically significant improvement was observed in manometric or pH-impedance variables in either group. Dysphagia (48% vs. 10%, p<0.001) and post-procedural pain (27% vs. 4%, p=0.012) were more frequent in the ARMA group. No cases of perforation or bleeding were recorded.

Conclusions The ARMA technique was not superior to sham endoscopy in PPI-dependent GERD patients, with a higher incidence of adverse effects. Our results do not support its implementation in clinical practice.