Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Mean upper esophageal sphincter mean resting pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean upper esophageal sphincter mean resting pressure
时间窗: mean value based on 30 seconds measurement of a subject
mean pressure of the upper esophageal sphincter
Mean IRP
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: mean value based on 30 seconds measurement of a subject
mean pressure of the upper esophageal sphincter
次要结局
未报告次要终点
研究者
Vasily Isakov
MD, PhD, Professor, AGAF
Russian Academy of Medical Sciences
