論文種別 原著(症例報告除く)
言語種別 英語
査読の有無 その他(不明)
表題 Multicenter Validation Study of the Clinical Diagnostic Criteria for IgG4-Related Sclerosing Cholangitis 2020 in Japan.
掲載誌名 正式名:Journal of hepato-biliary-pancreatic sciences
略  称:J Hepatobiliary Pancreat Sci
ISSNコード:18686982/18686974
掲載区分国外
巻・号・頁 pp.Online ahead of print
著者・共著者 Itaru Naitoh, Takahiro Nakazawa, Kensuke Kubota, Takayoshi Nishino, Akira Nakamura, Dai Inoue, Takanori Sano, Kazuhiro Kikuta, Yusuke Kurita, Kazuro Chiba, Tsukasa Ikeura, Hiroyuki Matsubayashi, Takuya Ishikawa, Masaki Kuwatani, Terumi Kamisawa, Ichiro Yasuda, Mitsuhiro Kawano, Atsushi Masamune,
発行年月 2026/01
概要 BACKGROUND:The diagnostic performance of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020 (IgG4-SC2020) has not been fully validated since its proposal as a revision of the 2012 criteria (IgG4-SC2012).METHODS:We conducted a multicenter validation study to evaluate the diagnostic performance of IgG4-SC2020 using clinical data collected from 1034 patients with IgG4-SC and 447 patients with mimickers, including 143 with pancreatic cancer, 157 with primary sclerosing cholangitis, and 147 with cholangiocarcinoma in Japan.RESULTS:The sensitivity of IgG4-SC2020 was significantly higher than that of IgG4-SC2012 (99.0% vs. 89.1%; p < 0.001). The specificities of both IgG4-SC2020 and IgG4-SC2012 were 100% for pancreatic cancer and cholangiocarcinoma. For primary sclerosing cholangitis, the specificities of IgG4-SC2020 and IgG4-SC2012 were 97.5% and 100%, respectively, with no significant difference (p = 0.123). A total of 113 patients who could not be diagnosed according to the IgG4-SC2012 were successfully diagnosed using IgG4-SC2020. These diagnostic improvements were attributed to the inclusion of MRCP findings (n = 97), the absence of neoplastic cells on histology (n = 15), and the presence of IgG4-related kidney lesions (n = 1).CONCLUSIONS:This Japanese multicenter validation study demonstrated that the diagnostic performance of IgG4-SC2020 was superior to that of IgG4-SC2012.TRIAL REGISTRATION:UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052984.
DOI 10.1002/jhbp.70056
PMID 41500843