Analyzing reflux disease and esophagitis after a specific esophageal procedure
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
This study looks at how common acid reflux and related issues are in patients with achalasia after they have a specific procedure called POEM.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT05080634 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with achalasia who have undergone peroral endoscopic myotomy (POEM). It aims to identify the prevalence of reflux esophagitis and asymptomatic gastroesophageal reflux disease (GERD) in these patients, as well as evaluate various patient and procedural factors that may contribute to post-POEM GERD. By utilizing high-resolution esophageal manometry, the study seeks to gather comprehensive data on the outcomes of this minimally invasive treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with achalasia and have undergone POEM.
Not a fit: Patients who do not have achalasia or those who cannot undergo esophagogastroscopy and high-resolution esophageal manometry will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of post-procedure complications, leading to improved management strategies for patients with achalasia.
How similar studies have performed: While this study addresses a specific aspect of post-POEM outcomes, similar studies have shown varying results regarding the prevalence of GERD after esophageal procedures, indicating that this area is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Warsaw
- Maria Sklodowska-Curie Institute - Oncology Center — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Anna Chaber-Ciopińska, PhD — The Maria Sklodowska-Curie National Research Institute of Oncology
- Study coordinator: Anna Chaber-Ciopińska, PhD
- Email: annachaber@op.pl
- Phone: (+48) 225463044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.