PMID- 37842961
OWN - NLM
STAT- MEDLINE
DCOM- 20240215
LR  - 20240215
IS  - 1440-1746 (Electronic)
IS  - 0815-9319 (Linking)
VI  - 39
IP  - 2
DP  - 2024 Feb
TI  - Nationwide multicenter study on adverse events associated with a patency capsule: 
      Additional survey of appropriate use of patency capsule study.
PG  - 337-345
LID - 10.1111/jgh.16365 [doi]
AB  - 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).
CI  - (c) 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & 
      Sons Australia, Ltd.
FAU - Omori, Teppei
AU  - Omori T
AUID- ORCID: 0000-0002-9959-5168
AD  - Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.
FAU - Ohmiya, Naoki
AU  - Ohmiya N
AUID- ORCID: 0000-0002-7651-402X
AD  - Department of Advanced Endoscopy, Fujita Health University School of Medicine, 
      Toyoake, Japan.
FAU - Watanabe, Kenji
AU  - Watanabe K
AD  - Department of Internal Medicine for Inflammatory Bowel Disease, Toyama 
      University, Toyama, Japan.
FAU - Hirai, Fumihito
AU  - Hirai F
AD  - Department of Gastroenterology and Medicine, Fukuoka University Faculty of 
      Medicine, Fukuoka, Japan.
FAU - Nakamura, Masanao
AU  - Nakamura M
AUID- ORCID: 0000-0002-5444-143X
AD  - Department of Gastroenterology and Hepatology, Nagoya University Graduate School 
      of Medicine, Nagoya, Japan.
FAU - Kitamura, Kazuya
AU  - Kitamura K
AD  - Department of Gastroenterology, Tonami General Hospital, Toyama, Japan.
FAU - Ozeki, Keiji
AU  - Ozeki K
AD  - Department of Gastroenterology and Metabolism, Nagoya City University Graduate 
      School of Medical Sciences, Nagoya, Japan.
FAU - Oka, Shiro
AU  - Oka S
AUID- ORCID: 0000-0002-1652-0743
AD  - Department of Gastroenterology, Hiroshima University, Hiroshima, Japan.
FAU - Kawano, Seiji
AU  - Kawano S
AD  - Department of Gastroenterology and Hepatology, Okayama University Graduate School 
      of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
FAU - Handa, Osamu
AU  - Handa O
AD  - Depatment of Gastroenterology, Kawasaki Medical School, Okayama, Japan.
FAU - Kawai, Mikio
AU  - Kawai M
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Hyogo Medical University, Nishinomiya, Japan.
FAU - Ninomiya, Kazeo
AU  - Ninomiya K
AD  - Ninomiya Internal Medicine Clinic, Saga, Japan.
FAU - Sagawa, Tamotsu
AU  - Sagawa T
AD  - Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan.
FAU - Wakamatsu, Takahiro
AU  - Wakamatsu T
AD  - Wakamatsu Clinic, Osaka, Japan.
AD  - Department of Gastroenterology and Hepatology, Kansai Medical University, Osaka, 
      Japan.
FAU - Araki, Akihiro
AU  - Araki A
AD  - Health Management Center, Toranomon Hospital, Tokyo, Japan.
FAU - Koike, Yuji
AU  - Koike Y
AD  - Department of Gastroenterology, Yokohama Municipal Citizen's Hospital, Yokohama, 
      Japan.
FAU - Kato, Shingo
AU  - Kato S
AUID- ORCID: 0000-0002-9030-0474
AD  - Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama 
      Medical University, Saitama, Japan.
FAU - Hashimoto, Shinichi
AU  - Hashimoto S
AD  - Department of Gastroenterology and Hepatology, Yamaguchi University Graduate 
      School of Medicine, Yamaguchi, Japan.
FAU - Mannami, Tomohiko
AU  - Mannami T
AUID- ORCID: 0000-0002-8564-5080
AD  - Department of Gastroenterology, National Hospital Organization Okayama Medical 
      Center, Okayama, Japan.
AD  - Department of Internal Medicine, Chugoku Central Hospital, Hiroshima, Japan.
FAU - Nakaji, Konosuke
AU  - Nakaji K
AD  - Endoscopy Center, Aishinkai Nakae Hospital, Wakayama, Japan.
FAU - Tanaka, Shinji
AU  - Tanaka S
AD  - Department of Endoscopy and Medicine, Graduate School of Biomedical and Health 
      Sciences, Hiroshima University, Hiroshima, Japan.
FAU - Matsui, Toshiyuki
AU  - Matsui T
AD  - Fukuoka University, Fukuoka, Japan.
CN  - J-POP study group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20231016
PL  - Australia
TA  - J Gastroenterol Hepatol
JT  - Journal of gastroenterology and hepatology
JID - 8607909
RN  - 25722-33-2 (parylene)
RN  - 0 (Polymers)
RN  - 0 (Xylenes)
SB  - IM
MH  - Humans
MH  - Retrospective Studies
MH  - *Capsule Endoscopy/adverse effects
MH  - Prospective Studies
MH  - *Intestinal Obstruction/epidemiology/etiology
MH  - Abdominal Pain/etiology
MH  - *Polymers
MH  - *Xylenes
OTO - NOTNLM
OT  - PillCam patency capsule
OT  - adverse event
OT  - parylene coating
OT  - retention
OT  - tag-less patency capsule
FIR - Abe, Takashi
IR  - Abe T
IRAD- Department of Gastroenterology, Hanwa Sumiyoshi General Hospital, Osaka, Japan.
FIR - Bamba, Shigeki
IR  - Bamba S
IRAD- Division of Endoscopy, Shiga University of Medical Science, Otsu, Japan.
FIR - Esaki, Motohiro
IR  - Esaki M
IRAD- Department of Gastroenterology, Saga University Hospital, Saga, Japan.
FIR - Hayashida, Mari
IR  - Hayashida M
IRAD- Department of Gastroenterology, Kyorin University Hospital, Tokyo, Japan.
FIR - Hasegawa, Daisuke
IR  - Hasegawa D
IRAD- Department of Gastroenterology, Ayabe City Hospital, Kyoto, Japan.
FIR - Higaki, Shingo
IR  - Higaki S
IRAD- Department of Gastroenterology, St. Hill Hospital, Yamaguchi, Japan.
FIR - Hiramoto, Tomoki
IR  - Hiramoto T
IRAD- Department of Endoscopy, Hiroshima Prefectural Hospital, Hiroshima, Japan.
FIR - Hodo, Yuji
IR  - Hodo Y
IRAD- Department of Gastroenterology, Saiseikai Kanazawa Hospital, Kanazawa, Japan.
FIR - Iwamoto, Maho
IR  - Iwamoto M
IRAD- Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Nihon University School of Medicine, Tokyo, Japan.
FIR - Kanayama, Kenji
IR  - Kanayama K
IRAD- Department of Gastroenterology, Sasaguri Hospital, Fukuoka, Japan.
FIR - Katsurahara, Masaki
IR  - Katsurahara M
IRAD- Department of Endoscopic Medicine, Mie University Graduate School of Medicine, 
      Tsu, Japan.
FIR - Kojima, Yuichi
IR  - Kojima Y
IRAD- Division of Internal Medicine, Hanwa Sumiyoshi General Hospital, Osaka, Japan.
FIR - Mizukami, Kazuhiro
IR  - Mizukami K
IRAD- Department of Gastroenterology, Oita University, Oita, Japan.
FIR - Naganuma, Makoto
IR  - Naganuma M
IRAD- Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
FIR - Nagasaka, Mitsuo
IR  - Nagasaka M
IRAD- Department of Gastroenterology, Fujita Health University School of Medicine, 
      Toyoake, Japan.
FIR - Nishiyama, Ryu
IR  - Nishiyama R
IRAD- Department of Gastroenterology, Hiratsuka Kyosai Hospital, Hiratsuka, Japan.
FIR - Nouda, Sadaharu
IR  - Nouda S
IRAD- Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
FIR - Osawa, Satoshi
IR  - Osawa S
IRAD- Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School 
      of Medicine, Shizuoka, Japan.
FIR - Sameshima, Yukinori
IR  - Sameshima Y
IRAD- Sameshima Hospital, Kagoshima, Japan.
FIR - Shibatoge, Mitsushige
IR  - Shibatoge M
IRAD- Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, 
      Takamatsu, Japan.
FIR - Shiotani, Akiko
IR  - Shiotani A
IRAD- Department of Internal Medicine, Division of Gastroenterology, Kawasaki Medical 
      School, Okayama, Japan.
FIR - Suga, Tomoaki
IR  - Suga T
IRAD- Department of Gastroenterology, Japanese Red Cross Suwa Hospital, Nagano, Japan.
FIR - Tokuhara, Daisuke
IR  - Tokuhara D
IRAD- Department of Pediatrics, Wakayama Medical University, Wakayama, Japan.
FIR - Ueno, Erina
IR  - Ueno E
IRAD- Department of Gastroenterology, St. Mary's Hospital, Fukuoka, Japan.
EDAT- 2023/10/16 12:41
MHDA- 2024/02/15 06:43
CRDT- 2023/10/16 07:13
PHST- 2023/08/21 00:00 [revised]
PHST- 2023/06/09 00:00 [received]
PHST- 2023/09/10 00:00 [accepted]
PHST- 2024/02/15 06:43 [medline]
PHST- 2023/10/16 12:41 [pubmed]
PHST- 2023/10/16 07:13 [entrez]
AID - 10.1111/jgh.16365 [doi]
PST - ppublish
SO  - J Gastroenterol Hepatol. 2024 Feb;39(2):337-345. doi: 10.1111/jgh.16365. Epub 
      2023 Oct 16.