Prolonged,wireless pH‐studies have a high diagnostic yield in patients with reflux symptoms and negative 24‐h catheter‐based pH‐studies

Background Catheter‐based esophageal pH‐monitoring is used to evaluate patients with suspected gastro‐esophageal reflux disease (GERD); however false‐negative results may occur due to poor tolerance of the catheter with reduced oral intake and activity, or high day‐to‐day variation in reflux and symptom events. We assessed diagnostic yield and clinical impact of prolonged, wireless pH‐monitoring in patients with negative results from 24‐h catheter‐based studies and ongoing symptoms. Methods Esophageal acid exposure (percentage time pH <4), Symptom Index, and Symptom Association Probability (SAP) were calculated. Diagnostic yield was assessed using Average (mean) and Worst Day (24‐h period with highest acid exposure or symptom load) analyses. Outcome data were assessed 6–36 months (median 24) after initiation of definitive therapy based on physiologic testing. Key Results Data from prolonged pH‐monitoring up to 96‐h (median 72‐h) were available from 38 patients. Using Average and Worst Day analysis, esophageal acid exposure was pathologic in 37% and 47%, whereas SAP was positive in 34% and 63% of patients, respectively. Overall using Average and Worst Day analyses, 61% and 76% patients were diagnosed with GERD based on either pathologic acid exposure or positive symptom association. Of 12 patients that underwent antireflux surgery, 10(83%) reported a good outcome at a median 24 months follow‐up. Conclusions & Inferences Prolonged, wireless pH‐monitoring increases test sensitivity and diagnostic yield in patients with continuing esophageal symptoms despite negative 24‐h catheter‐based pH‐studies. Without a definitive diagnosis, many would not have received effective treatment.