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Search / Trial NCT04065516

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

Launched by COORDINACIÓN DE INVESTIGACIÓN EN SALUD, MEXICO · Aug 20, 2019

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Achalasia Gastroesophageal Reflux Argon Plasma Coagulation Peroral Endoscopic Myotomy

ClinConnect Summary

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 s...

Gender

ALL

Eligibility criteria

  • 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

About Coordinación De Investigación En Salud, Mexico

Coordinación de Investigación en Salud, Mexico, is a leading clinical trial sponsor dedicated to advancing medical research and enhancing public health outcomes. With a robust infrastructure and a commitment to ethical standards, the organization collaborates with a network of healthcare professionals and institutions to conduct innovative clinical studies across various therapeutic areas. By leveraging cutting-edge methodologies and adhering to rigorous regulatory guidelines, Coordinación de Investigación en Salud aims to generate high-quality evidence that informs clinical practices and contributes to the development of safe and effective treatments for diverse populations.

Locations

Mexico City, , Mexico

Patients applied

0 patients applied

Trial Officials

Oscar V Hernandez, MD

Principal Investigator

Instituto Mexicano del Seguro Social

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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