Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study
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|ClinicalTrials.gov Identifier: NCT02081404|
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-erosive Reflux Disease||Drug: Esomeprazole Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Esomeprazole
proton pump inhibitor
standard dose of proton pump inhibitor by mouth once a day for 30 days
Other Name: Nexium
Placebo Comparator: Placebo
Other Name: inactive substance
- NBI endoscopy identifies changes in the distal esophagus that are specific for diagnosing patients with Non-Esophageal Reflux Disease. [ Time Frame: 10 weeks ]
- Proportion of patients with NBI abnormalities in the NERD group vs. controls.
- Proportion of patients with resolution of NBI abnormalities after PPI therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081404
|Contact: April D Higbee, RN, BSN||816-861-4700 ext firstname.lastname@example.org|
|United States, Missouri|
|Department of Veterans Affairs Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Contact: April D. Higbee, R.N., B.S.N. 816-861-4700 ext 7456 email@example.com|
|Principal Investigator: Prateek Sharma, MD|
|Queen Medical Center||Active, not recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Principal Investigator:||Prateek Sharma, M.D.||VA Office of Research and Development|