Confocal Laser Microscopy in Non Erosive Reflux Disease

Heartburn Clinical Trial

Official title:

Confocal Laser Microscopy in Non Erosive Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588939
• Other study ID #: 07-006186
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: May 17, 2013
• Start date: November 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acid Reflux Disease
• Gastroesophageal Reflux
• Heartburn

Intervention

Device:
• Cell~vizio (Laser connfocal microscopy)
completed during endoscopy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD		at time of procedure	No
Secondary	To assess the additional charges of implementing CLM in EGD		at time of procedure	No

External Links

•   Barrett's Esophagus Research Unit
•   Mayo Clinic Clinical Trials