Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease

Image-Enhanced Endoscopy for the Diagnosis of Non-Erosive Reflux Disease: A Prospective Case-Control Trial

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.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Other: Controls & Cases

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
    • West Haven, Connecticut, United States, 06516
      • VACHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.)

Description

Inclusion Criteria:

• Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs

Exclusion Criteria:

• Patients who have evidence of erosive esophagitis under white-light endoscopy
• Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
• Patients unable or unwilling to sign informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls & Cases; Controls (participants without heartburn or other GERD symptoms undergoing standard upper endoscopy for the following: anemia, weight loss, diarrhea, and screening for esophageal varices) and Cases (participants with heartburn or other GERD symptoms undergoing standard endoscopy for heartburn or other GERD symptoms.)	Other: Controls & Cases; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)	Once--at endoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence or absence of micro-erosions identified by endoscopist using IEE	Once at endoscopy
Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)	Once at endoscopy

Collaborators and Investigators

• Sponsor: Loren Laine
• Investigators: Principal Investigator: Loren Laine, MD, Yale University, VACHS

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (ESTIMATE): December 11, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: GERD; heartburn; NERD; non-erosive reflux disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: HIC1503015486; 0005 (VACHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED