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临床试验/NCT01202929
NCT01202929撤回不适用

Correlation of High Resolution Esophageal Manometry With Symptoms

University of Louisville1 个研究点 分布在 1 个国家开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Differences and similarities in patients with achalasia

研究概览

简要总结

High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the esophagus. It includes a sophisticated software to display the pressures data as color topography plot using time, length of the esophagus and pressure within the entire esophagus. It is unclear if this technology improvement actually correlates with patient's symptoms.

详细描述

In a 2007 retrospective study performed using this technology, 400 subjects referred to the motility lab underwent high resolution manometry (HRM) for complaints of dysphasia, gastroesophageal reflux disease, chest pain and miscellaneous complaints. HRM offered greater detail of individual contracting segments of the esophagus, including the duration of contraction and propagation of individual contractions.

For example, a new subclass of achalasia was defined by HRM. In this classification, achalasia is divided into types 1, 2 and 3. Type 1 corresponds to classic achalasia (complete esophageal motor failure), type 2 is a compression achalasia (simultaneous panesophageal pressurization with aperistalsis), and type 3 is spastic achalasia with aperistalsis (100% spasm). However, it is unclear if this categorization represents a spectrum of disease among patients with achalasia, or it represents distinct subgroups of patients with different symptom presentation and etiology.

This study will attempt to correlate the data from HRM to patient's chief compliants, symptom severity, and clinical presentation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.

排除标准

  • Pregnancy
  • Unable to give consent
  • Less than 18 years old

结局指标

主要结局

Differences and similarities in patients with achalasia

时间窗: at 24 months

To determine the differences and similarities in the clinical presentation of patients with type 1, 2 and 3 achalasia based on the Chicago classification for HRM

次要结局

  • Esophageal dysmotility in patients with postfundoplication compliants(at 24 months)
  • HRM parameters(at 24 months)
  • Correlation between HRM and symptoms(At 24 months)
  • Esophageal dysmotility in patients with dysphagia and GERD symptoms(at 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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