Unsedated peroral wireless pH capsule placement vs. standard pH testing: A randomized study and cost analysis

Abstract

BackgroundWireless capsule pH-metry (WC) is better tolerated than standard nasal pH catheter (SC), but endoscopic placement is expensive. Aims: to confirm that non-endoscopic peroral manometric placement of WC is as effective and better tolerated than SC and to perform a cost analysis of the available esophageal pH-metry methods.MethodsRandomized trial at 2 centers. Patients referred for esophageal pH testing were randomly assigned to WC with unsedated peroral placement or SC after esophageal manometry (ESM). Primary outcome was overall discomfort with pH-metry. Costs of 3 different pH-metry strategies were analyzed: 1) ESM + SC, 2) ESM + WC and 3) endoscopically placed WC (EGD + WC) using publicly funded health care system perspective.Results86 patients (mean age 51 ± 2 years, 71% female) were enrolled. Overall discomfort score was less in WC than in SC patients (26 ± 4 mm vs 39 ± 4 mm VAS, respectively, p = 0.012) but there were no significant group differences in throat, chest, or overall discomfort during placement. Overall failure rate was 7% in the SC group vs 12% in the WC group (p = 0.71). Per patient costs ($Canadian) were $1475 for EGD + WC, $1014 for ESM + WC, and $906 for ESM + SC. Decreasing the failure rate of ESM + WC from 12% to 5% decreased the cost of ESM + WC to $991. The ESM + SC and ESM + WC strategies became equivalent when the cost of the WC device was dropped from $292 to $193.ConclusionsUnsedated peroral WC insertion is better tolerated than SC pH-metry both overall and during placement. Although WC is more costly, the extra expense is partially offset when the higher patient and caregiver time costs of SC are considered.Trial registrationClinicaltrials.gov Identifier NCT01364610

Wireless Ph Monitoring and Conventional Esophageal Ph Monitoring: Comparative Study of Discomfort, Limitations in Daily Activities and Complications

“…The present and Andrews et al 2 studies observed that there was no significant difference between the capsule or catheter introduction. However, Gillies et al 11 showed less discomfort in the introduction of the capsule (p<0.0001).…”

“…By comparing discomfort and interference in routine activities between wireless and conventional pH test, during the monitoring, Andrews et al, Gillies et al, and Wong et al 2,11,34 observed better tolerability of the capsule. There was significantly less discomfort (nasal pain, runny nose, cervical pain, cervical discomfort and headache), as well as less interference in daily activities (general activities, eating, work and sleep) 2,11,34 .…”

Economic Evaluations of Gastroesophageal Reflux Disease Medical Management

“…The majority of articles (n=15) used a public healthcare system perspective ( e.g . UK NHS, US Medicare) [9–17,19–23,26]. One study used an employer cost perspective [18], one used a societal perspective [24], and one used a third party payer perspective [25].…”

Is topical lidocaine beneficial before catheter insertion in esophageal manometry and ambulatory pH monitoring?

“…In this questionnaire (which is presented in its original French version and a translated English version in the Appendix S1), patients rate their overall experience (overall discomfort, overall pain, overall psychological distress, whether they would do the test again, and global satisfaction), as well as the occurrence of various adverse effects (pain, discomfort, nausea, vomiting, coughing, choking, or others), and their severity (on a scale of 1 to 10) during three test phases: (a) catheter insertion, (b) test recording, and (c) in patients undergoing apH only, at home recording. This questionnaire was developed before the study and is based on Andrews et al's patient questionnaire and the American Society for Gastrointestinal Endoscopy (ASGE) patient satisfaction survey for endoscopy…”