TY - JOUR
T1 - Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn’s disease in Japan (SPREAD-J study)
AU - the SPREAD-J group
AU - Sakurai, Toshiyuki
AU - Omori, Teppei
AU - Tanaka, Hiroki
AU - Ito, Takahiro
AU - Ando, Katsuyoshi
AU - Yamamura, Takeshi
AU - Nanjjo, Sohachi
AU - Osawa, Satoshi
AU - Takeda, Teruyuki
AU - Watanabe, Kenji
AU - Hiraga, Hiroto
AU - Yamamoto, Shuji
AU - Ozeki, Keiji
AU - Tanaka, Shinji
AU - Tajiri, Hisao
AU - Saruta, Masayuki
AU - Akutagawa, Tsuyoshi
AU - Aoyama, Nobuo
AU - Iguchi, Toshihiro
AU - Endo, Katsuya
AU - Esaki, Motohiro
AU - Ogata, Haruhiko
AU - Oka, Shiro
AU - Omiya, Naoki
AU - Kagaya, Takeshi
AU - Kakimoto, Kazuki
AU - Kobayashi, Taku
AU - Sagami, Shintaro
AU - Sakuraba, Hirotake
AU - Shinzaki, Shinichiro
AU - Sugimoto, Ken
AU - Takao, Masaki
AU - Torisu, Takehiro
AU - Nakajima, Atsushi
AU - Nakamichi, Konosuke
AU - Nakamura, Masanao
AU - Nakase, Hiroshi
AU - Nishiyama, Ryuhei
AU - Hayashi, Yukie
AU - Hayashida, Mari
AU - Hiraoka, Sakiko
AU - Fuijya, Mikihiro
AU - Fukada, Norimasa
AU - Fukuda, Masayuki
AU - Mihara, Hiroshi
AU - Yokoyama, Kaoru
AU - Yoshida, Yuicihiro
AU - Wagatsuma, Kohei
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/10
Y1 - 2023/10
N2 - Background: Evidence of small-bowel capsule endoscopy (SBCE) for evaluating lesions in Crohn’s disease (CD) is lacking. We aimed to clarify the effectiveness and safety of SBCE in a large sample of patients with CD. Methods: This multicenter prospective registration study recorded the clinical information and SBCE results of patients with definitive CD (d-CD) or suspected CD (s-CD). The primary outcomes were the rates of successful assessment of disease activity using SBCE, definitive diagnosis of CD, and adverse events. Secondary outcomes were the assessment of SBCE findings in patients with d-CD and s-CD and factors affecting SBCE incompletion and retention; and tertiary outcomes included the association between clinical disease activity or blood examination, endoscopic disease activity, ileal CD, and the questionnaire assessment of patient acceptance of SBCE. Results: Of 544 patients analyzed, 541 underwent SBCE with 7 (1.3%) retention cases. Of 468 patients with d-CD, 97.6% could be evaluated for endoscopic activity. Of 76 patients with s-CD, 15.8% were diagnosed with ‘confirmed CD’. CD lesions were more frequently observed in the ileum and were only seen in the jejunum in 3.4% of the patients. Male sex and stenosis were risk factors for incomplete SBCE, and high C-reactive protein levels and stenosis were risk factors for capsule retention. In L1 (Montreal classification) patients, clinical remission was associated with endoscopic remission but showed low specificity and accuracy. The answers to the acceptability questionnaire showed the minimal invasiveness and tolerability of SBCE. Conclusion: SBCE is practical and safe in patients with CD.
AB - Background: Evidence of small-bowel capsule endoscopy (SBCE) for evaluating lesions in Crohn’s disease (CD) is lacking. We aimed to clarify the effectiveness and safety of SBCE in a large sample of patients with CD. Methods: This multicenter prospective registration study recorded the clinical information and SBCE results of patients with definitive CD (d-CD) or suspected CD (s-CD). The primary outcomes were the rates of successful assessment of disease activity using SBCE, definitive diagnosis of CD, and adverse events. Secondary outcomes were the assessment of SBCE findings in patients with d-CD and s-CD and factors affecting SBCE incompletion and retention; and tertiary outcomes included the association between clinical disease activity or blood examination, endoscopic disease activity, ileal CD, and the questionnaire assessment of patient acceptance of SBCE. Results: Of 544 patients analyzed, 541 underwent SBCE with 7 (1.3%) retention cases. Of 468 patients with d-CD, 97.6% could be evaluated for endoscopic activity. Of 76 patients with s-CD, 15.8% were diagnosed with ‘confirmed CD’. CD lesions were more frequently observed in the ileum and were only seen in the jejunum in 3.4% of the patients. Male sex and stenosis were risk factors for incomplete SBCE, and high C-reactive protein levels and stenosis were risk factors for capsule retention. In L1 (Montreal classification) patients, clinical remission was associated with endoscopic remission but showed low specificity and accuracy. The answers to the acceptability questionnaire showed the minimal invasiveness and tolerability of SBCE. Conclusion: SBCE is practical and safe in patients with CD.
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U2 - 10.1007/s00535-023-02017-3
DO - 10.1007/s00535-023-02017-3
M3 - Article
C2 - 37479808
AN - SCOPUS:85165308538
SN - 0944-1174
VL - 58
SP - 1003
EP - 1014
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
IS - 10
ER -