NCT03829865

Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

High resolution esophageal manometry normative values are still need to be studied in different populations and with the use of solid-state and water-perfused systems. There has been no study on the subject in healthy Russian population yet.

Detailed description

High-resolution esophageal manometry (HREM) is the current modality used to evaluate esophageal motility. There are 2 types of system: water-perfused system that is cheaper to maintain and a solid-state system that is considered to be more sensitive. According to the data obtained in the study of 400 patients and 75 controls by J Pandolfino et al it was proposed to use a common algorithm of HREM data interpretation and the normative values of the parameters used to interpret the color plots of HREM. This formed the basis for the first version of the currently used HREM reporting algorithm and classification of esophageal motility disorders called Chicago Classification (CC). To date, this classification has been updated several times by the International Working Group based on the recently published data. The Working group stated that the proposed normative values still need to be widely studied for each HREM system and in different populations. Some studies has been published recently on the normative values of HREM in different countries (predominantly in the US, in some European countries, Korea, India and China. But there has been no study on the subject in Russia still.

Conditions

• Healthy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	High resolution esophageal manometry	High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study

Timeline

• Start date: 2019-02-04
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2019-02-04
• Last updated: 2021-04-26

Locations

3 sites across 1 country: Russia

Regulatory

• FDA-regulated device study