OMORI Teppei
   Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position  
Article types Original article
Language English
Peer review Non peer reviewed
Title Nationwide multicenter study on adverse events associated with a patency capsule: Additional survey of appropriate use of patency capsule study
Journal Formal name:Journal of gastroenterology and hepatology
Abbreviation:J Gastroenterol Hepatol
ISSN code:14401746/08159319
Domestic / ForeginForegin
Volume, Issue, Page 39(2),pp.337-345
Author and coauthor OMORI Teppei,OHMIYA Naoki,WATANABE Kenji,HIRAI Fumihito,NAKAMURA Masanao,KITAMURA Kazuya,OZEKI Keiji,OKA Shiro,KAWANO Seiji,HANDA Osamu,KAWAI Mikio,NINOMIYA Kazeo,SAGAWA Tamotsu,WAKAMATSU Takahiro,ARAI Akihiro,KOIKE Yuji,KATO Shingo,HASHIMOTO Shinichi,MANNAMI Tomohiko,NAKAJI Konosuke,TANAKA Shinji,MATSUI Toshiyuki
Authorship Lead author
Publication date 2024/02
Summary 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).
DOI 10.1111/jgh.16365
PMID 37842961