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

3155105

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.

2009-03-01

2020-01-05

2020-08-05

Completed

98

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}

2023-03-16