Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study (NCT02081404) | Clinical Trial Compass
CompletedNot Applicable
Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study
United States, United Kingdom98 participantsStarted 2009-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NBI endoscopy identifies changes in the distal esophagus that are specific for diagnosing patients with Non-Esophageal Reflux Disease.