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The evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. Assessing esophageal peristalsis has relied for the past several decades on High Resolution Manometry (HRM), however it has recently become known that even though HRM is an extremely effective tool, that there are certain subsets of patients in which additional information is required. Additionally, the assessment of esophageal reflux disease has relied on pH impedance for the last two decades. However, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. Novel techniques, already FDA approved, including EndoFLIP for esophageal peristalsis and mucosal integrity (MI) for reflux disease, have emerged as time-of-endoscopy assessments. Both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. However, data regarding normal esophageal parameters are poorly defined for both EndoFLIP and MI. Additionally, EndoFLIP has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the GI tract.
We will recruit healthy, asymptomatic volunteers to undergo testing with MI and FLIP (esophageal and pyloric). The data obtained will help establish the benchmark from which assessments can be made in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal studies | Diagnostic Test | Healthy subjects will undergo esophageal and blood testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normative mucosal integrity values | We will establish the range of MI values in healthy, asymptomatic individuals. | 1 year |
| Normative pyloric FLIP values | We will further establish the range of FLIP values that can be seen in healthy, asymptomatic individuals. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 18-85 years of age, free of esophageal symptoms, never diagnosed with esophageal disorders, never diagnosed with an autoimmune disease, able to provide informed consent, and willing and able to undergo esophageal physiologic studies and biopsies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Healthcare | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Up to 10 research biopsies will be taken from the sides of your esophagus. An additional 2 research biopsies will be taken from the stomach. Additional esophageal biopsies may be taken at the discretion of the gastroenterologist performing the endoscopy if clinically indicated to be analyzed by the hospital's pathology department.
Each biopsy taken for research purposes will be processed and stored by a code that will not contain any personal information.
Samples of tissue from the esophageal biopsy will also be frozen and stored for future unspecified research, including comparing them to other disease populations.
| D004066 | Digestive System Diseases |