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Long-Term Wireless pH Monitoring of the Distal Esophagus: The Prolongation of the Test Beyond 48 Hours Is Not Necessary and May Be Misleading
Giovanni Capovilla*, Renato Salvador, Lorenzo Spadotto, Guerrino Voltarel, Elisa Pesenti, Loredana Nicoletti, Laura Gobbi, Stefano Merigliano, Mario Costantini
University of Padova, Padova, Italy
Wireless pH-monitoring of the esophagus has been widely used to detect GERD for more than a decade. It is generally well tolerated and accepted by the patients, but it is still unclear whether or not achieving prolonged recording beyond the usual 48-hour time can improve the diagnostic value of the test. Our study aimed to evaluate the diagnostic yield of 96-hour pH-monitoring over the 24- and 48-hour tests, and to ascertain if any gain in diagnostic value corresponded to a real clinical utility.
METHODS: 153 patients with suspected GERD underwent wireless prolonged pH-monitoring of the distal esophagus. PPI-therapy was withdrawn at least 2 weeks before the test. The capsule was positioned under endoscopic control, 5 cm above the upper border of the LES manometrically detected. Due to the device limitations, patients were asked to come back after 48 hours in order to restart the recording for other 48 hours. The DeMeester’s parameters were calculated for each day of the test. The test was considered abnormal when at least two parameters of the evaluated day exceeded the normal values of our laboratory.
RESULTS: 101 patients completed the 96-h test, and constitute the basis of our study, whereas 52 completed only the first 48-h of the test, and were therefore excluded from further analysis. Fifty-eight patients (57.4%) underwent this study because of intolerance to the traditional pH-catheter, while 43 patients (42.6%) had a previous negative pH-study despite symptoms suggestive for GERD. Thirty-six patients had a pathological test in the first 24 hours (35.6%, Group A); additional 12 patients had the test positive in the 2nd day (+ 11.9%, Group B); and other 7 patients (+ 6.9%, Group C) showed pathological acid exposure only in the 3rd or 4th day of the study. All the 55 patients with abnormal acid exposure were offered surgical (14 patients) or medical therapy. Clinical follow-up was obtained in 99/101 patients at a median of 68 months (IQR 37-94) months with a validated symptom-questionnaire. 88 % of Group A patients had a good outcome with fundoplication or medical therapy, whereas this was in 54.5% of Group B patients and only in 14.3% of Group C patients, p< 0.01.
CONCLUSIONS: Long-term wireless pH-monitoring allows only a small increase in the diagnostic yield over the traditional 24- and 48-hour pH-study. However, the prolongation of the test may constitute a unwanted bias and lead to a recruitment of “difficult” patients, in which the result of surgical or medical therapy may prove less than satisfactory. These results should be taken into account to define the guidelines for GERD assessment with this monitoring system
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