Confocal Laser Microscopy in Non Erosive Reflux Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
- •Patients who are able to give informed consent
Exclusion Criteria
- •Patients with a history of Erosive esophagitis
- •Patients with a history of Barrett's esophagus
- •Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
- •Patients who are unable or unwilling to undergo endoscopic evaluation
- •Patients who are unable to give informed consent
- •Patients with a known coagulopathy who are unable to be off therapy
Outcomes
Primary Outcomes
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
Time Frame: at time of procedure
Secondary Outcomes
- To assess the additional charges of implementing CLM in EGD(at time of procedure)
Investigators
Kenneth K. Wang
VanCleve Professor of Gastroenterology Research
Mayo Clinic