跳至主要内容
临床试验/NCT03829865
NCT03829865Unknown不适用

Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry

Russian Academy of Medical Sciences3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月4日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vasily Isakov

MD, PhD, Professor, AGAF

Russian Academy of Medical Sciences

研究点 (3)

Loading locations...

相似试验