Wireless esophageal pH capsule for patients with gastroesophageal reflux disease: A multicenter clinical study

摘要

AIM:To investigate the feasibility and safety of pH capsule to monitor pH in patients with gastroesophageal reflux disease(GERD).METHODS:Ninety-one patients with symptoms suggestive of GERD were enrolled in this study,46 of whom were randomized to the pH capsule group;the remaining 45 patients used the conventional catheter and pH capsule simultaneously.The pH data and traceswere recorded via automatic analysis,and capsule detachment was assessed using X-ray images.All of the patients were required to complete a questionnaire regarding tolerance with the capsule.RESULTS:The capsules were successfully attached on the first attempt,and no early detachment of the capsules was observed.Compared to the 24-h pH data recorded with the conventional catheter,the data collected with the pH capsule showed no significant differences in 24-h esophageal acid exposure.The measurements of esophageal acid exposure over 24 h collected with the two devices showed a significant correlation(r2=0.996,P<0.001).Capsule detachment occurred spontaneously in 89 patients,and 2 capsules required endoscopic removal due to chest pain.The capsule was associated with less interference with daily activity.CONCLUSION:The wireless pH capsule provides a feasible and safe method for monitoring gastroesophageal reflux and therefore may serve as an important tool for diagnosing GERD.