Confocal Laser Microscopy in Non Erosive Reflux Disease

Mayo Clinic

Status: Completed

Conditions: Heartburn; Acid Reflux Disease

Treatments: Device: Cell~vizio (Laser connfocal microscopy)

Study type: Observational

Funder types: Other

Identifiers

NCT00588939

07-006186

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
2. Patients who are able to give informed consent

Exclusion criteria

1. Patients with a history of Erosive esophagitis
2. Patients with a history of Barrett's esophagus
3. Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
4. Patients who are unable or unwilling to undergo endoscopic evaluation
5. Patients who are unable to give informed consent
6. Patients with a known coagulopathy who are unable to be off therapy

Trial design

60 participants in 1 patient group

I

Description:

participants with symptoms of acid reflux disease (heartburn)

Treatment:

Device: Cell~vizio (Laser connfocal microscopy)