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

Area of Science:

• Gastroenterology
• Medical Devices
• Health Economics

Background:

• Standard catheter pH-metry (SC) is invasive and less tolerated by patients.
• Wireless capsule (WC) pH-metry offers improved patient tolerance but traditionally requires expensive endoscopic placement.
• Esophageal pH monitoring is crucial for diagnosing gastroesophageal reflux disease (GERD).

Purpose of the Study:

• To compare the efficacy and tolerability of non-endoscopic peroral WC placement versus SC.
• To conduct a cost-effectiveness analysis of different esophageal pH-metry methods.
• To evaluate patient-reported discomfort during pH testing.

Main Methods:

• A randomized trial involving 86 patients undergoing esophageal pH testing.
• Patients were assigned to either WC with unsedated peroral placement or SC following esophageal manometry (ESM).
• Cost analysis included ESM + SC, ESM + WC, and endoscopically placed WC (EGD + WC) from a healthcare system perspective.

Main Results:

• WC placement resulted in significantly lower overall discomfort scores compared to SC (26 vs 39 mm VAS, p=0.012).
• No significant differences in discomfort during the placement procedure itself were observed between groups.
• Per-patient costs were $906 for ESM + SC, $1014 for ESM + WC, and $1475 for EGD + WC.

Conclusions:

• Unsedated peroral WC insertion is better tolerated than SC pH-metry.
• While WC is more expensive, its total cost is partially offset by reduced patient and caregiver time costs.
• Non-endoscopic WC placement presents a viable, well-tolerated alternative to SC.