Actively Recruiting
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2021-10-18
100
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Achalasia is a rare condition caused by the loss of nerve cells in the lower esophagus, leading to swallowing difficulties. Researchers are studying the occurrence of gastroesophageal reflux disease (GERD) and esophagitis in patients who have undergone peroral endoscopic myotomy (POEM), a minimally invasive treatment designed to address achalasia. This observational study aims to understand how often reflux and silent GERD appear after POEM and to identify factors linked to these outcomes. Participants in this study are achalasia patients who have had the POEM procedure. They will undergo various assessments before and after treatment, including scoring of symptoms, questionnaires about reflux symptoms, high-resolution esophageal pressure tests, endoscopic examinations, and pH monitoring to measure acid exposure. No new treatments are given; the study focuses on monitoring and evaluating the effects after POEM. During the study, participants will have follow-up evaluations over a period of up to 36 months to track the presence of reflux and esophagitis. Researchers will collect data on patient symptoms, test results, and procedural details to analyze risk factors associated with post-POEM GERD. The main outcome measured is the prevalence of gastroesophageal reflux after the procedure. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology and does not involve healthy volunteers.
CONDITIONS
Brief Title
Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females who are 18 years of age and older and willing to sign an Informed Consent Form
- Diagnosed with achalasia and have undergone peroral endoscopic myotomy (POEM)
You will not qualify if you...
- Lack of written consent for participation in the study
- Presence of conditions that prevent esophagogastroscopy or high-resolution esophageal manometry
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants undergo pre- and postoperative assessments including Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy, and pH monitoring.
Assessments occur before and after peroral endoscopic myotomy (POEM) over 36 months
Trial Site Locations
Total: 1 location
1
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Poland
Actively Recruiting
Research Team
A
Anna Chaber-Ciopińska, PhD
A
Aleksandra Budnicka-Borkowicz, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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