Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Recruiting

• Conditions: GERD; Achalasia

• Registration Number: NCT05080634
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-18
• Last Update Posted: 2021-10-18
• Primary Completion: 2024-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)	36 Months

Trial Locations

Locations (1)

Maria Sklodowska-Curie Institute - Oncology Center; 🇵🇱 Warsaw, Poland