Clinical Safety And Utility Of JSPH-1Wireless Esophageal PH Monitoring System

Background: Now, there are so many methods for clinical diagnosisof gastroesophageal reflux disease (GERD), but a few methods can provideobjective evidence. Abnormal acid exposure is the main pathologicalmechanism of GERD, esophageal pH monitoring serves an important rolein numerous methods, because it can quantify esophageal acid exposure,provide correlation between symptom and acid reflux, which seemsimportant for accurate diagnosis of GERD. With Technologic advances,wireless esophageal pH monitoring system with better safety andtolerability had been introduced, and the clinical application was extensivein foreign countries, but no application was reported in china.Aim: JSPH-1wireless pH monitoring system is designed by JinshanScience and Technology Company of Chongqing in china, we performed aclinical test to confirm the safety and tolerability of this new wireless pHmonitoring system, and evaluate whether it is feasible for clinical diagnosisof GERD.Methods: Patients from Department of Gastroenterology of First Affiliated Hospital of Chongqing Medical University from April2011toAugust2011, with typical symptoms (heartburn, regurgitation) and/oratypical symptoms (chest pain, asthma and chronic cough with no reason,chronic pharyngitis) of GERD, or PPI therapy test positive were fit forinclusion. All subjects underwent JSPH-1pH capsule for48-h pHmonitoring, the capsule was placed5cm proximal to the squamocolumnarjunction (SCJ) by endoscopic determination. After attachment, subjectscould go home and keep normal daily activities, the discomforts wererecorded.48-h later, pH data of day1, day2and48-h was downloaded andanalyzed respectively.Results: Thirty patients were placed JSPH-1pH capsule successfullywithout sedation. All subjects tolerated well and would like to repeat theoperation if necessary, there was no serious discomfort.29patientscompleted48-h data recording, no complications and interference of dailyactivities were reported during data monitoring. The capsulesspontaneously dislodged in29patients, no one complained of discomfort orlimitation of daily live during detachment.1patient complained of chestpain, the capsule was removed under endoscope, and then the pain wasrecovered gradually.48-h pH monitoring detected15patients of abnormalacid exposure, on day1detected9patients, the difference had statisticalsignificance (p<0.01). Positive symptom index (SI) was identified in3patients with normal pH data in both days, these patients should be included in GERD. In total,48-h monitoring made18patents diagnosis ofGERD, and increased diagnosis of9patients.Conclusion: The attachment of JSPH-1pH capsule can be operatedwithout sedation,48-h esophageal pH monitoring with JSPH-1wireless pHmonitoring system is safe, well tolerated. It is feasible for clinical diagnosisof GERD.