Healthy Clinical Trial
Official title:
Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria (all points are necessary for inclusion): - Willingness to participate on the basis of signed informed consent form; - Patients of both sexes, aged 18 to 65 years inclusive; - Permanent residence in the Russian Federation; - Absence of esophageal diseases, confirmed by the results of clinical and instrumental examination - Ability to follow instructions during high-resolution esophageal manometry procedure Exclusion Criteria (patient is not eligible when at least one exclusion criterion is met): - diseases of the esophagus (any condition on the basis of clinical and / or instrumental examination, including: complaints of heartburn, belching, difficulty to swallow solid and/or liquid food; - any surgical intervention on the gastrointestinal tract and / or chest organs in medical history; - solid organ transplantation in medical history with the exception of a corneal transplant and surgery to replace the lens of the eye; - any oncology of any localization except for skin cancer in situ in the medical history; - any decompensated diseases of any organs and systems, which, in the opinion of the researcher, makes it impossible to carry out the procedure of esophageal manometry of high resolution or if the procedure may cause the risk of deterioration of the patient's condition; - any condition, clinical and laboratory signs of alcohol abuse (abuse will be assessed in the case of male subjects consuming more than 30 g of pure alcohol per day and using more than 20 g of pure alcohol per day by female subjects; - any illegal drug use, current or past; - use of concomitant medications that can affect esophageal motility including, but not limited to: calcium channel blockers, metoclopramide, m-cholinolytics, domperidone, erythromycin, nitrates, tricyclic antidepressants, opiates, beta-blockers, beta-adrenomimetics, alcohol. The duration of the period of non-use of these drugs should provide sufficient time for the complete cessation of their pharmacological action, but not less than two half-life. - pregnant or breastfeeding women - any condition making impossible to perform high resolution esophageal manometry (previously known poor tolerability of the procedure; narrow nasal passages; significant curvature of the nasal septum etc). |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Gastroenterology and Hepatology, FRC Nutrition and Biotechnology | Moscow | |
Russian Federation | Moscow clinical hospital #31 | Moscow | |
Russian Federation | Pavlov First Saint Petersburg State Medical University. Endoscopy Department | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Russian Academy of Medical Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | Mean upper esophageal sphincter mean resting pressure | mean pressure of the upper esophageal sphincter | mean value based on 30 seconds measurement of a subject | |
Primary | 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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