Abstract
Ambulatory reflux monitoring is considered the gold standard for diagnosis of GERD but only provides a “snap shot” of a disease process that by definition is chronic in nature and can have false negative results in up to 30% of patients. Mucosal integrity (MI) testing is a minimally invasive, innovative test that can detect changes in esophageal mucosa instantly during endoscopy. The aim of this prospective blinded study was to assess the predictive value of MI as a diagnostic modality for the evaluation of suspected GERD refractory to therapy at index endoscopy without the need for ambulatory pH monitoring. Patients with suspected GERD-related symptoms with partial or incomplete response to acid suppressive therapy undergoing endoscopy and 48-hour wireless pH monitoring one week OFF treatment were enrolled in this study. During the endoscopy, MI values (Ω) were collected at 2, 5, and 10 cm above the squamocolumnar junction (SCJ). GERD was predicted (pre-wireless pH monitoring) based on low MI values distally and axial pattern of MI along the esophageal axis. A member of the research team (TH), blinded to the endoscopy images during the procedure and pH monitoring data, predicted GERD or non-GERD based on the MI pattern alone. Predictions were later compared to data from the ambulatory 48-hour wireless pH monitoring. 34 patients constituted the study population [70% female, median age 48]. Clinical symptoms were similar between the groups (heartburn, regurgitation). 24/34 patients were predicted to have GERD based on MI pattern during endoscopy [median MI at 2 cm of 1811 (1499-2676), at 5 cm of 2790 (2162-3508), and at 10 cm of 3823 (2724-4922)] and 10/34 were predicted to be normal [median MI at 2 cm of 3126 (2357-4042), at 5 cm of 5674 (5179-6267), and at 10 cm of 5403 (4339-5936)]. Median total % time pH <4 was 5.9 (4.8-10.2) in the predicted GERD group and 4.4 (2.5-6.9) in the non-GERD group (Table 1). 7/34 patients had erosive esophagitis (3 LA grade A, 4 LA grade B), which were all predicted to have GERD based on MI pattern. MI testing had a sensitivity of 83% with negative predictive value of 90% for AET of >12% (moderate to severe GERD). MI testing during endoscopy has high negative predictive value (90%) for moderate to severe reflux during endoscopy. In patients with incomplete or partial response to PPI negative MI testing would obviate the need for ambulatory pH monitoring.
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