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Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.
Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | participants with symptoms of acid reflux disease (heartburn) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell~vizio (Laser connfocal microscopy) | Device | completed during endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD | at time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the additional charges of implementing CLM in EGD | at time of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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age 18 - 65 years symptoms of acid reflux disease
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth K Wang, MD | Mayo Clinic | Study Director |
| Rami Badreddine, MD | Malyo Clinic Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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esophageal biopsy
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |