An observational study in Healthy, sponsored by Russian Academy of Medical Sciences. Status unknown at 3 sites in Russian Federation. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Russian Academy of Medical Sciences · Observational
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.
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.
Russian Academy of Medical Sciences is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study is aimed to evaluate high resolution esophageal motility parameters in subjects who have no signs of any esophageal disorders and are residents of Russia
Inclusion Criteria (all points are necessary for inclusion):
Exclusion Criteria (patient is not eligible when at least one exclusion criterion is met):
Healthy volunteers examined with water-perfused high resolution esophageal manometry
Diagnostic Test: High resolution esophageal manometry
Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter
Diagnostic Test: High resolution esophageal manometry
High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study
Mean IRP
Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean DCI
distal contractile integral - Amplitude x duration x length (mmHg x s x cm) of the distal esophageal contraction exceeding 20 mmHg from the transition zone to the proximal margin of the LES
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean DL
distal latency - Interval between UES relaxation and the contractile deceleration point
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean upper esophageal sphincter mean resting pressure
mean pressure of the upper esophageal sphincter
Time frame: mean value based on 30 seconds measurement of a subject
Mean lower esophageal sphincter mean resting pressure
mean pressure of the upper esophageal sphincter
Time frame: mean value based on 30 seconds measurement of a subject
Plan to share: Yes — Depersonalized individual data may be shared upon the study completion.
Supporting information: Study protocol, Sap, Csr
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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Russian Academy of Medical Sciences