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临床试验/NCT05851482
NCT05851482已完成不适用

NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE

IRCCS Policlinico S. Donato2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
246
试验地点
2
主要终点
HRM score

研究概览

简要总结

The goal of this prospective study is to validate a high resolution manometry score to predict pathologic GERD in patients with reflux symptoms. The main question it aims to answer is:

Is it possible to predict GERD on high resolution manometry? Participants will be asked to undergo high resolution manometry and pH-study

详细描述

According to recent guidelines, high resolution manometry (HRM) has an ancillary role in the diagnosis of gastro-esophageal reflux disease (GERD). A recent multicenter study demonstrated the effectiveness of the straight leg raise (SLR) maneuver in predicting GERD, thus increasing the diagnostic value of HRM in patients with suspected pathological reflux. HRM parameters associated with GERD include esophageal body hypomotility such as ineffective esophageal motility (IEM), and esophagogastric junction (EGJ) metrics, particularly the EGJ contractile integral (EGJ-CI) that takes into consideration the presence or absence of a hiatal hernia (HH), and a hypotensive lower esophageal sphincter (LES). The combination of these four parameters might help to predict or exclude true GERD in patients undergoing HRM with the suspicion of GERD.

In this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (AET>6%).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HRM and wireless pH-study or catheter pH-impedance study performed for persistent GERD symptoms off proton-pump inhibitor (PPI) within two weeks of each other,
  • SLR maneuver performed at the end of HRM

排除标准

  • Body mass index (BMI) >35 Kg/m2
  • prior esophageal surgery
  • paraesophageal hiatal hernia
  • eosinophilic esophagitis
  • scleroderma
  • esophageal achalasia

结局指标

主要结局

HRM score

时间窗: From date of inclusion in the study until the diagnosis of GERD, up to 2 months

HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral

次要结局

未报告次要终点

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Siboni

Medical Doctor

IRCCS Policlinico S. Donato

研究点 (2)

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