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Enrolling by Invitation

NCT Number: NCT04065516

ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With Achalasia

The peroral endoscopic myotomy for the treatment of achalasia is associated with a higher incidence of gastroesophageal reflux disease compared with Heller's myotomy. Remodeling of the esophagogastric junction with hybrid argon plasma could decrease the passage of gastric or gastroduodenal content into the esophagus.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Mexico City, 06700, Mexico

About this study

Achalasia is the inability of the lower esophageal sphincter to relax in the context of dysfunction of esophageal peristalsis. Peroral endoscopic myotomy for the treatment of achalasia has an efficacy above 90%, being comparable with Heller's myotomy. The treatment of achalasia by peroral endoscopic myotomy is associated with a higher incidence of gastroesophageal reflux disease, compared with alternative therapies such as Heller's myotomy or pneumatic dilatation. Hybrid argon plasma at the level of the esophagogastric junction could generate remodeling of this region generating a partial stenosis and thereby decrease the passage of gastric or gastroduodenal content into the esophagus.

A clinical trial will be carried out, including all patients with achalasia, treated by peroral myotomy older than 18 years old, with abnormal acid exposure in the pHmetry test 3 months or more after treatment, who accept the management of ablation with hybrid argon plasma. To whom the ablation will be performed with Hybrid Argon Plasma and its effectiveness will be evaluated by clinical questionnaires, endoscopy and pHmetry measurement at the beginning, 3 months, 6 months and 12 months after the procedure.

Demographic and clinical data will be recorded in a data collection sheet, detailing the reflux questionnaire(GERDQ), Eckardt score, endoscopic findings of esophagitis according to Los Angeles classification and abnormal acid exposure in each evaluation. The data will be condensed into a database for subsequent statistical analysis and publication of results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Achalasia type I, II, III
  • Treatment with POEM (Peroral Endoscopic Myotomy)
  • Abnormal acid exposure (>6%) in the 24h-pHmetry test more than three months after the procedure
  • Signed informed consent

Exclusion criteria

  • Patients who do not accept the treatment
  • Previous antireflux surgery
  • Previous Heller's Myotomy
  • Hiatal hernia greater than 3 centimeters
  • Hill's Classification Grade IV
  • Pregnancy
  • Patients with any contraindication for an endoscopy
  • Patients with esophageal or gastric varices

Treatment and study plan

ARAT technique

Procedure

After an initial endoscopic evaluation, ARAT technique will be performed with marking, submucosal elevation at esophagogastric junction and then ablation with 100-120w of 270-300 degrees at esophagogastric junction, once the application of the therapy is performed mucosal lavage and immersion technique will be made to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications.

Primary outcomes

  1. A change in erosive esophagitis grade assessed by upper endoscopy after ARAT

    Time frame: measures will be performed at 3,6 and 12 months after ARAT

    Upper endoscopy is going to be used to measure the erosive esophagitis grade using the Los Angeles Esophagitis scale(grade A=mild, Grade B=moderate, Grade C=moderate high and Grade D=severe) after after ARAT

  2. A change in esophageal acid exposure assessed by pHmetry study after ARAT

    Time frame: measures will be performed at 3,6 and 12 months after ARAT

    A 24-hours pHmetry study is going to be used to measure esophageal acid exposure in esophagus after ARAT. DeMeester Score and the percentage of esophagic acid exposure will be used to assess pathologic reflux (>14.73 and > 6%, respectively)

  3. A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT

    Time frame: measures will be performed at 3,6 and 12 months after ARAT

    The clinical evaluation of reflux disease is going to be assessed by the use of a clinical gastroesophageal reflux disease questionnaire (GERD-Q) after ARAT. Reflux disease was considered positive when >4 points is observed

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

Safety and Efficacy of Antireflux Ablation Therapy (ARAT) at Esophagogastric Junction in Patients With Reflux Disease After Peroral Endoscopic Myotomy (POEM) in Achalasia

Acronym: ARAT

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2019
Registry last updated
Apr 25, 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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