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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water-perfused HREM | Healthy volunteers examined with water-perfused high resolution esophageal manometry |
| |
| Solid-state HREM | Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High resolution esophageal manometry | Diagnostic Test | High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | mean value based on 30 seconds measurement of a subject |
| Mean lower esophageal sphincter mean resting pressure | mean pressure of the upper esophageal sphincter | mean value based on 30 seconds measurement of a subject |
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Inclusion Criteria (all points are necessary for inclusion):
Exclusion Criteria (patient is not eligible when at least one exclusion criterion is met):
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Morozov, MD, PhD | Contact | +74996131091 | morosoffsv@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Vasily Isakov, MD, PhD | Federal Research Center of Nutrition and Biotechnology | Study Chair |
| Sergey Morozov, MD, PhD | Federal Research Center of Nutrition and Biotechnology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and Hepatology, FRC Nutrition and Biotechnology | Recruiting | Moscow | 115446 | Russia |
Depersonalized individual data may be shared upon the study completion.
5 years
by request
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| Moscow clinical hospital #31 | Recruiting | Moscow | 119415 | Russia |
|
| Pavlov First Saint Petersburg State Medical University. Endoscopy Department | Recruiting | Saint Petersburg | 197022 | Russia |
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