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 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction