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NCT05080634 Clinical Trial

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

GERD Clinical Trial

Official title:
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05080634
Other study ID # 22042020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 1, 2026

Study information
Verified date October 2021
Source Maria Sklodowska-Curie Institute - Oncology Center
Contact Anna Chaber-Ciopinska, PhD
Phone (+48) 225463044
Email annachaber@op.pl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 1, 2026
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Patients who underwent POEM
chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.

Locations
Country Name City State
Poland Maria Sklodowska-Curie Institute - Oncology Center Warsaw

Sponsors (1)
Lead Sponsor Collaborator
Maria Sklodowska-Curie Institute - Oncology Center

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM) 36 Months
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