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

Non-erosive Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081404
• Other study ID #: 3155105
• Status: Completed
• Phase: N/A
• Start date: March 1, 2009
• Est. completion date: August 5, 2020

Study information

• Verified date: March 2023
• Source: Midwest Veterans' Biomedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 5, 2020
• Est. primary completion date: January 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• Esomeprazole
standard dose of proton pump inhibitor by mouth once a day for 30 days
• Placebo
placebo

Locations

Country	Name	City	State
United Kingdom	Queen Medical Center	Nottingham
United States	Department of Veterans Affairs Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Biomedical Research Foundation	Kansas City Veteran Affairs Medical Center

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NBI endoscopy identifies changes in the distal esophagus that are specific for diagnosing patients with Non-Esophageal Reflux Disease.	Proportion of patients with NBI abnormalities in the NERD group vs. controls.; Proportion of patients with resolution of NBI abnormalities after PPI therapy.	10 weeks