Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study

March 15, 2023 updated by: PRATEEK SHARMA, Midwest Biomedical Research Foundation
Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and helps to see abnormal areas not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of this study is to accurately diagnosis non acid reflux disease by using a blue light (also known as NBI)upper endoscopy technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from NERD; a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. 24-hour esophageal pH monitoring and histologic esophageal mucosal changes in NERD patients have limited accuracy to be routinely used in clinical practice.

Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and enables imaging of features such as intrapapillary capillary loops (IPCLs); features not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. Our hypothesis is that NBI identifies changes in the distal esophagus that are specific for diagnosing patients with NERD. Specific Aim #1: To compare NBI features in the distal esophagus in patients with NERD (cases) and controls. Specific Aim #2: To determine whether the NBI features in NERD patients resolve after PPI therapy. Specific Aim #3: To correlate NBI findings with esophageal histology. Specific Aim #4: To assess the intra- and interobserver agreement for recognition of the proposed criteria for diagnosing NERD. Cases will be defined as patients with reflux symptoms (assessed by two validated questionnaires) with absent macroscopic erosions and abnormal esophageal pH results (NERD group). Control subjects will include patients with no reflux symptoms, absent macroscopic erosions and a normal esophageal pH result. To identify NBI findings as predictors of response, response to therapy in cases randomized to the PPI arm will be assessed using a validated GERD questionnaire and correlated with IPCL number and presence of microerosion. In addition, NBI findings in patients with reflux symptoms, no macroscopic erosions and normal esophageal pH result will also be compared with controls. Two biopsies will be obtained from the distal esophagus along with digital images and videorecordings.

Statistical analysis will be done as follows: Aim 1 - chi-square and t-test; with logistic regression and calculation of odds ratios, Aim 2- McNemar's test and kappa statistic, Aim 3- Spearman's correlation coefficient and Aim 4- intraclass correlation coefficient. Potential impact on Health Care: GERD is common among patients and by obviating the need for additional investigations and reducing unnecessary drug costs, NBI endoscopy could have a considerable positive impact on patients with NERD.

VA Project

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Queen Medical Center
  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Department of Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • Capable of giving informed consents.
  • Cases of NERD will be recruited on the basis of presence of heartburn and/or regurgitation using two validated GERD questionnaires in conjunction with an abnormal esophageal pH result and absence of erosions at standard endoscopy.
  • Control subjects will include patients referred for an upper endoscopy for evaluation of non-reflux symptoms such as iron deficiency anemia, heme positive stools, screening of esophageal varices amongst others. A negative esophageal pH result and absence of erosions will be inclusion criteria for these patients.

Exclusion Criteria:

  • Presence of macroscopic erosive esophagitis
  • Pregnancy/lactation
  • Chronic anticoagulation
  • Patients with significant medical comorbidities (oxygen dependent chronic obstructive pulmonary disease, NYHA class III or IV congestive heart failure, recent diagnosis of cancer with a life-expectancy < 5 years)
  • History of Barrett's esophagus
  • Presence of columnar lined distal esophagus on endoscopy with intestinal metaplasia
  • Presence of cancer or mass lesion in the esophagus or stomach
  • Esophageal strictures
  • Peptic ulcer disease and Helicobacter pylori infection
  • Prior history of esophageal surgery
  • Allergic to PPIs
  • Patients on drugs known to cause pill-related esophagitis (e.g. potassium supplements)
  • Patients with HIV or other immunocompromised conditions who may have infectious esophagitis
  • Eosinophilic esophagitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Other Names:
  • inactive substance
Active Comparator: Esomeprazole
proton pump inhibitor
Drug: Esomeprazole
standard dose of proton pump inhibitor by mouth once a day for 30 days
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NBI endoscopy identifies changes in the distal esophagus that are specific for diagnosing patients with Non-Esophageal Reflux Disease.
Time Frame: 10 weeks
  1. Proportion of patients with NBI abnormalities in the NERD group vs. controls.
  2. Proportion of patients with resolution of NBI abnormalities after PPI therapy.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Kansas City Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Prateek Sharma, M.D., VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

January 5, 2020

Study Completion (Actual)

August 5, 2020

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3155105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants individual participant data collected in the study will be available to other researchers upon request. Participants will be identified by participant number, age, race and gender. This information will be available at the end of the study and may be requested via email to april.higbee@va.gov.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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