Evidence map›Paper›PMID 41500843›Full record

Observational studyJournal of hepato-biliary-pancreatic sciences2026

Multicenter Validation Study of the Clinical Diagnostic Criteria for IgG4-Related Sclerosing Cholangitis 2020 in Japan.

Itaru Naitoh, Takahiro Nakazawa, Kensuke Kubota, Takayoshi Nishino, Akira Nakamura, Dai Inoue, Takanori Sano, Kazuhiro Kikuta, Yusuke Kurita, Kazuro Chiba and 9 more

Abstract readMulticenter StudyObservational StudyValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of hepato-biliary-pancreatic sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Itaru NaitohDepartment of Gastroenterology, Nagoya City University Midori Municipal Hospital, Nagoya, Japan.ORCID https://orcid.org/0000-0001-8342-886X
Takahiro NakazawaDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID https://orcid.org/0000-0002-6321-5995
Kensuke KubotaDepartment of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan.
Takayoshi NishinoDepartment of Gastroenterology, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan.
Akira NakamuraDepartment of Medicine, Gastroenterology, Shinshu University, Matsumoto, Nagano, Japan.
Dai InoueDepartment of Radiology, Kanazawa University Hospital, Kanazawa, Japan.
Takanori SanoDivision of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kazuhiro KikutaDivision of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yusuke KuritaDepartment of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan.ORCID https://orcid.org/0000-0003-2482-6707
Kazuro ChibaDepartment of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
Tsukasa IkeuraThird Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan.
Hiroyuki MatsubayashiDivision of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Takuya IshikawaDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.ORCID https://orcid.org/0000-0001-5814-3555
Masaki KuwataniDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Terumi KamisawaDivision of Gastroenterology and Center of IgG4-Related Disease, Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
Ichiro YasudaThird Department of Internal Medicine, University of Toyama, Toyama, Japan.
Mitsuhiro KawanoDepartment of Hematology & Immunology, Kanazawa Medical University, Kahoku-Gun, Japan.ORCID https://orcid.org/0000-0003-4613-2116
Atsushi MasamuneDivision of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Japan Pancreatitis Study Group

Funding

Health and Labour Sciences Research Grants for the Study of Intractable Diseases from the Ministry of Health, Labor and Welfare, Japan 23FC1015Nagoya City University
6 · The paper itself

Abstract

backgroundThe 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).

methodsWe 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.

resultsThe 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).

conclusionsThis Japanese multicenter validation study demonstrated that the diagnostic performance of IgG4-SC2020 was superior to that of IgG4-SC2012.

trial registrationUMIN Clinical Trials Registry (UMIN-CTR), UMIN000052984.

Indexed as

Cholangitis, SclerosingImmunoglobulin GImmunoglobulin G4-Related DiseaseAdultAgedBile Duct NeoplasmsDiagnosis, DifferentialFemaleHumansJapanMaleMiddle AgedRetrospective StudiesSensitivity and SpecificityImmunoglobulin Gautoimmune pancreatitischolangiocarcinomaIgG4‐related diseaseIgG4‐related sclerosing cholangitisprimary sclerosing cholangitis

Identifiers

PMID41500843
PMCPMC13113202

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.