NCT05080634 Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
| NCT ID | NCT05080634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Condition | Achalasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2024-06-01 |
Trial Parameters
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Brief Summary
Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.
Eligibility Criteria
Inclusion Criteria: 1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF) 2. Achalasia patients who underwent POEM Exclusion Criteria: 1. Lack of written consent for participation in the study 2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry