Nationwide multicenter study on adverse events associated with a patency capsule: Additional survey of appropriate use of patency capsule study

Teppei Omori, Naoki Ohmiya, Kenji Watanabe, Fumihito Hirai, Masanao Nakamura, Kazuya Kitamura, Keiji Ozeki, Shiro Oka, Seiji Kawano, Osamu Handa, Mikio Kawai, Kazeo Ninomiya, Tamotsu Sagawa, Takahiro Wakamatsu, Akihiro Araki, Yuji Koike, Shingo Kato, Shinichi Hashimoto, Tomohiko Mannami, Konosuke NakajiShinji Tanaka, Toshiyuki Matsui, Takashi Abe, Shigeki Bamba, Motohiro Esaki, Mari Hayashida, Daisuke Hasegawa, Shingo Higaki, Tomoki Hiramoto, Yuji Hodo, Maho Iwamoto, Kenji Kanayama, Masaki Katsurahara, Yuichi Kojima, Kazuhiro Mizukami, Makoto Naganuma, Mitsuo Nagasaka, Ryu Nishiyama, Sadaharu Nouda, Satoshi Osawa, Yukinori Sameshima, Mitsushige Shibatoge, Akiko Shiotani, Tomoaki Suga, Daisuke Tokuhara, Erina Ueno

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)337-345
Number of pages9
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume39
Issue number2
DOIs
Publication statusPublished - 02-2024

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

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