Clinical trial: Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy (NCT00954070)

Eligibility criteria:
Inclusion Criteria:

          -  Cases:

               -  male or female patients aged between 21 and 65 years with typical clinical
                  manifestations of gastroesophageal reflux but endoscopy-negative for esophageal
                  mucosal breaks

               -  by typical clinical manifestations of gastroesophageal reflux, we refer to the
                  occurrence of heartburn and/or regurgitation more than twice a week, with a
                  minimum duration of 8 consecutive weeks, and with symptoms severe enough to
                  affect daily activities

          -  Controls:

               -  healthy male or female aged between 21 and 65 years who are asymptomatic for GERD
                  and other digestive diseases

        Exclusion Criteria:

          -  Endoscopic confirmed erosive esophagitis

          -  Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer,
             stenosis

          -  Esophageal, gastric or duodenal cancer or other malignancy

          -  History of esophagus, stomach, or duodenum surgery

          -  Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,
             and patients on warfarin and antiplatelets)

          -  Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy or any
             underlying disease or medication that might affect the lower esophageal sphincter
             pressure or increase the acid clearance time

          -  A history of bronchial asthma, or known allergy to fluorescein

          -  Pregnant or breast-feeding (for females)

          -  Below 21 or above 65 years of age

          -  Severe co-morbidities (e.g., such as end-stage renal failure, congestive cardiac
             failure, liver cirrhosis, severe arthritis requiring long term non-steroidal
             anti-inflammatory drug therapy)

          -  Unable or unwilling to give informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 65 Years

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