Extended 72-hour patency capsule protocol improves functional patency rates in high-risk patients undergoing capsule endoscopy.

Abstract

Background: Capsule endoscopy (CE) is a pivotal diagnostic tool for gastrointestinal (GI) disorders, yet capsule retention poses a significant risk, especially in patients with known risk factors. The patency capsule (PC) helps assess the functional patency of the GI tract to mitigate this risk. However, the standard 28-hour protocol for confirming patency often results in high false-positive rates, unnecessarily excluding many patients from undergoing diagnostic CE.

Aim: To investigate the use of a 72-hour extended patency protocol to improve functional patency rates in patients at risk of capsule retention.

Methods: We performed a prospective, open-label study evaluating an extended 72-hour protocol for confirming functional patency with the PC. Conducted over six months, 135 patients with risk factors for capsule retention were enrolled. The primary endpoint was the capsule retention rate in patients with confirmed functional patency. Secondary endpoints included the rates of confirmed patency via self-reporting or radiology, small bowel transit times, and adverse events.

Results: Functional patency was confirmed in 48.9% (n = 66) of patients within 28 hours, with an additional 17.4% (n = 12) confirmed within 72 hours, increasing the overall patency rate to 57.8%. There was no significant difference in small bowel transit time between patients confirmed for patency at 28 hours vs those confirmed at 72 hours. Importantly, no capsule retention was observed in patients who were confirmed for patency under the extended protocol. Notably, 50% (n = 39) of patients who proceeded to CE had clinically significant findings.

Conclusion: Extending the patency assessment protocol to 72 hours significantly improves the rate of confirmed functional patency without increasing the risk of capsule retention. This protocol is safe, effective, and cost-neutral, allowing more patients to benefit from CE. Further studies are recommended to refine the protocol and enhance its clinical utility.