Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Degree of lower esophageal sphincter contraction and relaxation
研究概览
简要总结
The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
详细描述
Achalasia is a disease characterized by inadequate opening of the lower esophageal sphincter. Achalasia is presumed to be due to neuronal dysfunction (active), however there are other variables such as muscle layer fibrosis (passive) that may contribute, particularly in milder or earlier achalasia variants. A new technology, impedance planimetry, may be able to measure active vs passive features of the lower esophageal sphincter (LES).
The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Male or female patients, age 18 and above.
- •Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1,
- •Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)
- •Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)
- •Undergoing Heller myotomy or per-oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)
- •8 healthy control esophageal samples will be obtained from the NDRI donor program for Aim 2.
排除标准
- •Patients younger than 18 years old
- •Pregnant women
- •Prisoners
- •Non-English-speaking patients - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.
- •Cognitively impaired adults unable to provide informed consent
- •Cardiac disease in the form of - arrhythmia requiring intracardiac defibrillator (ICD) or pacemaker, baseline bradycardia with HR <60 or tachycardia with a heart rate (HR) > 90, congestive heart failure with ejection fraction <35%, history of myocardial infarction, baseline mean arterial pressure (MAP) <65 or systolic blood pressure (BP) >140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, glomerular filtration rate (GFR) <60 [exclusions for Aim 1 only]
研究组 & 干预措施
Pharmacologic challenge
Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)
干预措施: Atropine challenge (Drug)
Esophageal muscle biopsy
Patients with a diagnosis of an esophageal motility disorder who are undergoing Heller myotomy, per-oral endoscopic myotomy, or esophagectomy for treatment of their esophageal motility disorder.
干预措施: Esophageal muscle biopsy (Procedure)
Normal esophageal tissues
Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments.
结局指标
主要结局
Degree of lower esophageal sphincter contraction and relaxation
时间窗: Two minutes after the study drugs administration
Degree of lower esophageal sphincter contraction and relaxation will be measured
The collagen content in muscle biopsy specimens
时间窗: Two minutes after the study drugs administration
The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.
次要结局
未报告次要终点
研究者
Anand Jain
Principal Investigator
Emory University