Non-invasive Markers of Esophageal Function in Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Presence of diagnostic pattern
研究概览
简要总结
The investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.
详细描述
Dysphagia, or difficulty with swallowing, is a common symptom affecting nearly 9.4 million individuals or 4% of the US population. High resolution esophageal manometry is currently considered the gold standard test for evaluation and diagnosis of esophageal motility disorders, but given that it requires trans-nasal placement in a conscious patient, this test is highly uncomfortable and associated with significant patient dissatisfaction. There are currently no noninvasive tests or markers available to test esophageal function and motility.
In the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. Recent modifications of the standard electrogastrogram (EGG) that have increased the number of leads to 25 (termed high-resolution EGG) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. Additionally, the magnetogastrogram (MGG) overcomes many of the inherent limitations of the standard EGG. The goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (EESG) and magnetoesophagogram (MESG) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients.
The main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using EESG/MESG in healthy controls and esophageal dysmotility patients and determine how EESG/MESG rhythm and pattern abnormalities relate to physiologic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years of age who are undergoing HRM for routine standard of care evaluation for esophageal motility.
- •Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.
排除标准
- •Those with claustrophobia who cannot lie still under the SQUID for the length of time required
- •Due to interference with signal acquisition, subjects with contraindication to undergoing an MRI scan as noted in the MRI Safety checklist by Vanderbilt University Medical Center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo SQUID, but can still be eligible to do cutaneous EESG.
- •Morbid obesity (these patients are potentially unable to lie under the current generation of SQUID devices)
- •Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded
研究组 & 干预措施
Achalasia subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: Clinical measure questionnaires (Other)
Achalasia subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: EESG (Diagnostic Test)
Achalasia subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: MESG (Diagnostic Test)
Achalasia subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: High resolution manometry (HRM) (Diagnostic Test)
Hypercontractile/spastic disorder subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: Clinical measure questionnaires (Other)
Hypercontractile/spastic disorder subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: EESG (Diagnostic Test)
Hypercontractile/spastic disorder subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: MESG (Diagnostic Test)
Hypercontractile/spastic disorder subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: High resolution manometry (HRM) (Diagnostic Test)
Healthy Controls
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: Clinical measure questionnaires (Other)
Healthy Controls
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: EESG (Diagnostic Test)
Healthy Controls
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
干预措施: MESG (Diagnostic Test)
结局指标
主要结局
Presence of diagnostic pattern
时间窗: 3 months
EESG and MESG wave patterns will be used to see if there is a diagnostic pattern that helps identify normal function vs. the motility disorders (achalasia or hypercontractile/spastic disorders)
次要结局
未报告次要终点
研究者
Dhyanesh Patel
Principal Investigator
Vanderbilt University Medical Center