Clinical trial NCT04803162: The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
Official title: The Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eosinophilic Esophagitis
Keywords: eosinophilic esophagitis
eotaxin 3
major basic protein
interleukin 5
interleukin 13
transforming growth factor beta 1
high-resolution manometry
Gastrointestinal Quality of Life index
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized at the Department of Gastroenterology and Hepatology and the Department of Otolaryngology, Head and Neck Surgery at Wroclaw Medical University in Poland from 1.11.2017 to 31.12.2021 for endoscopic diagnosis of dysphagia.

Brief summary: The aim of the project is to assess the correlation between the results of high-resolution oesophageal manometry and specific biomarkers of inflammation (eotaxin 3, major basic protein, IL-5, IL-13, TGF-beta1) with symptoms of dysphagia, endoscopic and histological features and the assessment of quality of life in patients with eosinophilic esophagitis.

Research hypothesis: The results of high resolution esophageal manometry (HRM) and specific inflammatory biomarkers correlate with symptoms of dysphagia, endoscopic and histological features, and assessment of quality of life in patients with eosinophilic oesophagitis. HRM, along with the determination of specific inflammatory biomarkers present in the peripheral blood, may serve as a less invasive method of assessing the effectiveness of the treatment of eosinophilic oesophagitis in relation to the currently used endoscopic examinations.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age,
* patients referred for endoscopic diagnostics due to dysphagia.

Exclusion Criteria:

* already diagnosed chronic diseases with possible eosinophilic infiltration of the gastrointestinal tract (eosinophilic esophagitis, eosinophilic gastroenteritis, Crohn's disease, celiac disease),
* rheumatological, dermatological and genetic disorders with possible peripheral eosinophilia,
* dysphagia caused by a diagnosed neoplastic infiltration of the esophagus.

Primary outcomes:
measure: High-resolution manometry
timeFrame: 3 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Gastrointestinal Quality of Life index
timeFrame: 3 months
Secondary outcomes:
measure: High-resolution manometry in the group of patients with EoE
timeFrame: 3 months
measure: Serum biomarkers in the group of patients with EoE
timeFrame: 3 months
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Gastroenterology and Hepatology, Wroclaw Medical University
state: Borowska 213
Study officials:
affiliation: Department of Gastroenterology and Hepatology, Wroclaw Medical University
name: Dorota Waśko-Czopnik, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarbinowska J, Wiatrak B, Wasko-Czopnik D. Esophageal Motility Disorders in the Natural History of Acid-Dependent Causes of Dysphagia and Their Influence on Patients' Quality of Life-A Prospective Cohort Study. Int J Environ Res Public Health. 2021 Oct 23;18(21):11138. doi: 10.3390/ijerph182111138.