Key result
Tag-less PillCam patency capsule examinations were associated with a 2.37% adverse event rate, most commonly residual parylene coating (0.97%) and small bowel obstruction (0.89%).
Why the study?
The PillCam patency capsule without a radio frequency identification tag was released in Japan in 2012, prompting a multicenter study to determine tag-less patency capsule-related adverse events.
What are the adverse events associated with a tag-less patency capsule in patients undergoing small bowel capsule endoscopy?
Cohort (n=2,578)
Yes
What are the adverse events associated with a tag-less patency capsule in patients undergoing small bowel capsule endoscopy?
The tag-less patency capsule has a low adverse event rate (2.37%), supporting its safety and efficiency to preclude capsule endoscope retention.
May warrant caution with tag-less PC in CE; leaves open need for confirmatory safety data.
BACKGROUND AND AIM: The PillCam patency capsule (PC) without a radio frequency identification tag was released to preclude retention of the small bowel capsule endoscope (CE) in Japan in 2012. We conducted a multicenter study to determine tag-less PC-related adverse events (AEs). METHODS: We first conducted a retrospective survey using a standardized data collection sheet for the clinical characteristics of PC-related AEs among 1096 patients collected in a prospective survey conducted between January 2013 and May 2014 (Cohort 1). Next, we retrospectively investigated additional AEs that occurred before and after Cohort 1 within the period June 2012 and December 2014 among 1482 patients (Cohort 2). RESULTS: Of the 2578 patients who underwent PC examinations from both cohorts, 74 AEs occurred among 61 patients (2.37%). The main AEs were residual parylene coating in 25 events (0.97%), PC-induced small bowel obstruction, suspicious of impaction, in 23 events (0.89%), and CE retention even after patency confirmation in 10 events (0.39%). Residual parylene coating was significantly associated with Crohn's disease (P < 0.01). Small bowel obstruction was significantly associated with physicians with less than 1 year of experience handling the PC and previous history of postprandial abdominal pain (P < 0.01 and P < 0.03, respectively). CE retention was ascribed to erroneous judgment of PC localization in all cases. CONCLUSIONS: This large-scale multicenter study provides evidence supporting the safety and efficiency of a PC to preclude CE retention. Accurate PC localization in patients without excretion and confirmation of previous history of postprandial abdominal pain before PC examinations is warranted (UMIN000010513).
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Omori et al. (2023) conducted a cohort in Patients undergoing PillCam patency capsule examinations (n=2,578). Tag-less PillCam patency capsule was evaluated on PC-related adverse events (AEs). Tag-less PillCam patency capsule examinations were associated with a 2.37% adverse event rate, most commonly residual parylene coating (0.97%) and small bowel obstruction (0.89%).
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