Clinical trial: Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study (NCT02081404)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment