Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
- Conditions
- Healthy
- Interventions
- Diagnostic Test: High resolution esophageal manometry
- Registration Number
- NCT03829865
- Lead Sponsor
- Russian Academy of Medical Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Water-perfused HREM High resolution esophageal manometry Healthy volunteers examined with water-perfused high resolution esophageal manometry Solid-state HREM High resolution esophageal manometry Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter
- Primary Outcome Measures
Name Time Method Mean upper esophageal sphincter mean resting pressure mean value based on 30 seconds measurement of a subject mean pressure of the upper esophageal sphincter
Mean IRP mean value of 10 swallows by 30 seconds (about 7 minutes per subject) Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation
Mean DCI mean value of 10 swallows by 30 seconds (about 7 minutes per subject) 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 DL mean value of 10 swallows by 30 seconds (about 7 minutes per subject) distal latency - Interval between UES relaxation and the contractile deceleration point
Mean lower esophageal sphincter mean resting pressure mean value based on 30 seconds measurement of a subject mean pressure of the upper esophageal sphincter
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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, Russian Federation