Status:
ENROLLING_BY_INVITATION
ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With Achalasia
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Achalasia
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04065516
Start Date
July 3 2019
End Date
December 1 2026
Last Update
April 25 2025
Active Locations (1)
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1
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico, 06700