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

Last updated: April 23, 2025
Sponsor: Coordinación de Investigación en Salud, Mexico
Overall Status: Active - Enrolling

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Achalasia

Treatment

ARAT technique

Clinical Study ID

NCT04065516
R-2019-3601-135
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 afterthe procedure

  • Signed informed consent

Exclusion

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

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: ARAT technique
Phase:
Study Start date:
July 03, 2019
Estimated Completion Date:
December 01, 2026

Study Description

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.

Connect with a study center

  • Centro Medico Nacional Siglo XXI Hospital de Especialidades

    Mexico City, 06700
    Mexico

    Site Not Available

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