Clinical trial NCT00588939: Confocal Laser Microscopy in Non Erosive Reflux Disease
Official title: Confocal Laser Microscopy in Non Erosive Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acid Reflux Disease
Heartburn
Keywords: reflux
heartburn
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age 18 - 65 years symptoms of acid reflux disease

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

Eligibility criteria: 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

Primary outcomes:
measure: To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
timeFrame: at time of procedure
Secondary outcomes:
measure: To assess the additional charges of implementing CLM in EGD
timeFrame: at time of procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenneth K Wang, MD
role: STUDY_DIRECTOR
affiliation: Malyo Clinic Rochester
name: Rami Badreddine, MD
role: PRINCIPAL_INVESTIGATOR
References: