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

BMC Gastroenterology

Steven J Heitman²  Flora Au²  Martin Storr¹  Emil Neshev²  Chad Williams²  Adriana Lazarescu³  Daniel C Sadowski³  Christopher N Andrews² 

[1] Ludwig Maximilians University, Munich, Germany;Division of Gastroenterology, University of Calgary, Calgary, Canada;GI Motility Lab, University of Alberta Hospital, Edmonton, AB, Canada

关键词: Clinical trial;    pH-metry;    Gastroesophageal reflux disease;    Esophagus;   

Others  :  1113059
DOI  :  10.1186/1471-230X-12-58

 received in 2012-01-05, accepted in 2012-05-31,  发布年份 2012

【 摘 要 】

Background

Wireless 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.

Methods

Randomized 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.

Results

86 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.

Conclusions

Unsedated 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 registration

Clinicaltrials.gov Identifier NCT01364610

【 授权许可】

   
2012 Andrews et al.; licensee BioMed Central Ltd.

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