Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not
      respond to conventional treatment (a class of medications called proton pump inhibitors), it
      is important to be able to distinguish between erosive GERD and non-erosive GERD (called
      NERD).

      Currently the best method the investigators have to make this distinction is esophageal
      24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus
      through the nose and having the catheter maintained in this position for 24 hours This test
      is invasive, can be uncomfortable, and it is expensive and time consuming.

      The investigators are hoping that image enhanced technology will identify characteristics
      that are found more commonly in patients with non-erosive GERD compared to controls and
      therefore provide evidence that may allow us to replace pH and impedance testing with the
      image enhanced endoscopy as the best way to diagnose NERD.

      Participants will be either patients undergoing an upper endoscopy as part of their standard
      clinical evaluation for heartburn that does not respond to PPIs or patients undergoing
      standard clinical evaluation endoscopy for other reasons.
    

Detailed description: 
      Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive
      reflux disease (NERD), defined as heartburn documented to be associated with reflux on
      impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE)
      during initial endoscopy.

      The investigators will examine the following characteristics for IEE sensitivity,
      specificity, positive predictive values, and negative predictive value: squamo-columnar
      junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these
      characteristics. The investigators will also look at abnormal morphology of intra-papillary
      capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and
      assess the identification of their presence using I-scan. Additionally, the investigators
      will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of
      reflux disease) and analyze obtained images and results to calculate inter-observer
      agreement.

      IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).

      Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at
      locations specified in this record will be invited to participate.
    

Intervention name(s): Controls & Cases
Intervention type(s): Other
Intervention description(s): All interventions are standard of care and both controls and cases will be treated the same. IEE results from controls and cases will be compared.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Controls (participants scheduled for upper endoscopy for anemia, weight loss, diarrhea, or
        screening for esophageal varices and who do not have heartburn or other GERD symptoms and
        Cases (participants scheduled for upper endoscopy for heartburn or other GERD symptoms.)
      
Keywords: heartburn; GERD; NERD; non-erosive reflux disease