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

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05080634
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia; GERD	Other: Patients who underwent POEM

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Sep 1, 2026

Outcome Measures

Primary Outcome Measures

1. The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM) [36 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maria Sklodowska-Curie Institute - Oncology Center	Warsaw		Poland

Sponsors and Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

• Principal Investigator: Anna Chaber-Ciopińska, PhD, The Maria Sklodowska-Curie National Research Institute of Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
• ClinicalTrials.gov Identifier: NCT05080634
• Other Study ID Numbers: 22042020
• First Posted: Oct 18, 2021
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maria Sklodowska-Curie National Research Institute of Oncology: Peroral endoscopic myotomy; High-resolution esophageal manometry
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis

Study Results

No Results Posted as of Oct 18, 2021