Comparison of stationary vs ambulatory 24-hour pH monitoring systems in diagnosis of gastroesophageal reflux disease.

Twenty-four-hour intraesophageal pH monitoring is presently considered the most reliable diagnostic test for gastroesophageal reflux. Prolonged esophageal pH measurements can be obtained in hospitalized patients with a stationary technique and in ambulant outpatients by means of a portable device; however, there have been no studies that have examined whether the two approaches provide a similar diagnostic accuracy. We performed a prospective study to compare stationary and ambulatory pH-metry in the diagnosis of gastroesophageal reflux. Seventy-seven control subjects and 178 patients with proven gastroesophageal reflux disease were randomized to either ambulant or static pH-metry, which was performed with standard pH electrodes, sensors, and recorders. Reflux events (intraesophageal pH < 4.0) analyzed were: number of episodes; total, upright, and supine reflux time; number of episodes lasting > 5 min; and duration of the longest episode. A composite score of all reflux events according to DeMeester was also calculated. The limits of normality were defined as the 95th percentiles of the control groups. Both controls and patients assigned to either pH monitoring method were comparable. Of 255 studies attempted, 243 (95%) were completed successfully. The results showed similar median values of reflux events for the two control groups and for the two patients groups. Percent total reflux time provided a good separation between normal and abnormal reflux, with a sensitivity of 0.92 for static pH-metry and 0.68 for the ambulant procedure (respective 95th percentiles, 3.4 and 4.6).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes