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

    1   Ramón y Cajal Hospital, Madrid, Spain

  • C Teruel Sanchez-Vegazo

    1   Ramón y Cajal Hospital, Madrid, Spain

  • A Herreros De Tejada

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • I Marín Fernández

    3   Hospital Germans Trias i Pujol, Badalona, Spain

  • M P Diez Redondo

    4   Rio Hortega University Hospital, Valladolid, Spain

  • M H Nuñez Rodriguez

    4   Rio Hortega University Hospital, Valladolid, Spain

  • M De Benito Sanch

    4   Rio Hortega University Hospital, Valladolid, Spain

  • H Uchima

    3   Hospital Germans Trias i Pujol, Badalona, Spain

  • D Burgos Santamaría

    1   Ramón y Cajal Hospital, Madrid, Spain

  • J M Duque Alcorta

    5   Hospital Universitario San Agustín, Avilés, Aviles, Spain

  • D Perez Corte

    5   Hospital Universitario San Agustín, Avilés, Aviles, Spain

  • E Albéniz

    6   Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain

  • I Castel

    7   Hospital Universitario 12 de Octubre, Madrid, Spain

  • F Estremera-Arevalo

    6   Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain

  • J Arribas Anta

    7   Hospital Universitario 12 de Octubre, Madrid, Spain

  • M Ramirez Verdyguer

    1   Ramón y Cajal Hospital, Madrid, Spain

  • F Riu Pons

    8   Hospital del Mar, Barcelona, Spain

  • J E Naves

    8   Hospital del Mar, Barcelona, Spain

  • P Beatriz

    1   Ramón y Cajal Hospital, Madrid, Spain

  • S Parejo

    1   Ramón y Cajal Hospital, Madrid, Spain

  • A Martínez Sánchez

    1   Ramón y Cajal Hospital, Madrid, Spain

  • P De Maria Pallares

    9   La Paz University Hospital, Madrid, Spain

  • I Perez Enciso

    9   La Paz University Hospital, Madrid, Spain

  • C García Suarez

    10   Hospital de Cabueñes, Gijón, Spain

  • M Pipa Muñiz

    10   Hospital de Cabueñes, Gijón, Spain

  • J C Marin-Gabriel

    7   Hospital Universitario 12 de Octubre, Madrid, Spain

  • D de Frutos

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • J Santiago Garcia

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • V Matallana

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • V Lorenzo-Zúñiga

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

  • V Ortiz Bellber

    12   La Fe University and Polytechnic Hospital, València, Spain

  • A Arrubla

    6   Navarra Hospital Complex – Navarra Hospital, Pamplona, Spain

  • L Barranco Priego

    8   Hospital del Mar, Barcelona, Spain

  • A Muriel

    1   Ramón y Cajal Hospital, Madrid, Spain

  • L Del Campo Albendea

    1   Ramón y Cajal Hospital, Madrid, Spain

  • Ó Nogales Rincón

    13   Gregorio Marañón General University Hospital, Madrid, Spain

  • J García Lledó

    13   Gregorio Marañón General University Hospital, Madrid, Spain

  • I El Hajra Martínez

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • J Aranda Hernández

    13   Gregorio Marañón General University Hospital, Madrid, Spain

  • L Relea Pérez

    2   Puerta de Hierro Majadahonda University Hospital, Majadahonda, Spain

  • E Vazquez Sequeiros

    1   Ramón y Cajal Hospital, Madrid, Spain

  • A Albillos Martínez

    1   Ramón y Cajal Hospital, Madrid, Spain
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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.



Publication History

Article published online:
27 March 2025

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