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Completed

NCT Number: NCT04711655

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

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

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de San Agustín, Avilés, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Severe psychiatric disorder
  • Refusal to participate in the study.

Treatment and study plan

ARMA (antireflux ablation of the cardiac mucosa)

Procedure

is an endoscopy in which argon gas 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.

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.

    Time frame: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

    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.

Secondary outcomes

  1. GERD-Q questionnaire score

    Time frame: The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

    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%;

  2. PPI consumption

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

    Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied.

  3. pHmetry-impedancemetry

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

    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.

  4. High resolution manometry

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

    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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Spanish Society of Digestive Endoscopy

Registry information

Official study title

Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jan 15, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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