Original article
Clinical endoscopy
Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy

https://doi.org/10.1016/j.gie.2007.10.063Get rights and content

Background

Capsule endoscopy (CE) of the small bowel has become a standard diagnostic tool, but there have been concerns regarding the risk of capsule retention in certain high-risk groups. The Agile patency system, an ingestible and dissolvable capsule with an external scanner, was developed to allow physicians to perform CE with greater confidence that the capsule will be safely excreted in patients at risk for capsule retention.

Objective

Our purpose was to assess the ability of the device to help physicians identify which patients with known strictures may safely undergo CE.

Design

Patients with known strictures ingested the new patency capsule and underwent periodic scanning until it was excreted. The intestinal tract was considered to be sufficiently patent if the capsule was excreted intact or if the capsule was not detected by the scanner at 30 hours after ingestion. If patency was established, then standard CE was performed.

Setting

International multicenter study.

Patients

A total of 106 patients with known strictures.

Intervention

Agile patency system.

Main Outcome Measurements

Performance and safety of Agile patency system.

Results

A total of 106 patients ingested the patency capsule. Fifty-nine (56%) excreted it intact and subsequently underwent CE. There were no cases of capsule retention. Significant findings on CE were found in 24 (41%). There were 3 severe adverse events.

Conclusions

These results suggest that the Agile patency system is a useful tool for physicians to use before CE in patients with strictures to avoid retention. This group of patients may have a high yield of clinically significant findings at CE. This capsule may determine whether patients who have a contraindication to CE may safely undergo CE and obtain useful diagnostic information.

Section snippets

Patients and methods

Patients over 18 years of age with evidence of an intestinal stricture as detected by radiographic means, either CT or SBFT, were eligible for inclusion in this international multicenter study. Subjects with pacemakers or other implanted electromedical devices, swallowing disorders, or fewer than 2 bowel movements per week and pregnant women were excluded. The study was approved by the local ethics committee or institutional review board at each participating center, and written informed

Results

A total of 106 patients were enrolled in the study. The basic demographic characteristics of the study population are shown in Table 1. Patient characteristics including the presence of known Crohn's disease and symptoms were recorded at enrollment.

Of the 106 subjects enrolled, 59 (56%) excreted the Agile patency capsule intact and thereby demonstrated functional patency of the small intestine (Fig. 4). Forty-seven capsules (44%) were excreted in a deformed state. No capsules were found to have

Discussion

CE has been shown to be an extremely important tool in visualizing the small intestinal mucosa. Although it is generally considered a very safe procedure, there is a small chance of capsule retention within the small bowel. Among these patients with capsule retention, a very small minority may have a blockage of the small bowel requiring surgical intervention.10 Screening of patients before CE with SBFT has been shown to be inaccurate for predicting capsule retention. This study shows that the

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