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Concordance of the histological diagnosis of type 1 autoimmune pancreatitis and its distinction from pancreatic ductal adenocarcinoma with endoscopic ultrasound-guided fine needle biopsy specimens: an interobserver agreement study

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Abstract

The histological diagnosis of type 1 autoimmune pancreatitis (AIP) based on the findings obtained by an endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is feasible, but the diagnostic consistency of this method has not been confirmed. We determined the interobserver agreement among 20 pathologists regarding the diagnosis of type 1 AIP, including the distinction from pancreatic ductal adenocarcinoma (PDAC) using large tissue samples obtained by EUS-FNB. After guidance for diagnosing AIP with biopsy tissues was provided, a round 2 was performed. The median sensitivity and specificity for diagnosing PDAC vs. non-neoplastic diseases were 95.2% and 100%, respectively. In groups of specialists (n = 7) and the generalists (n = 13), Fleiss’ к-values increased from 0.886 to 0.958 and from 0.750 to 0.816 in round 2. The concordance was fair or moderate for obliterative phlebitis and storiform fibrosis but slight for ductal lesion of type 1 AIP. Discordant results were due to ambiguous findings and biopsy tissue limitations. Among the specialists, the ratio of cases with perfect agreement regarding the presence of storiform fibrosis increased in round 2, but agreement regarding obliterative phlebitis or ductal lesions was not improved. Although the histological definite diagnosis of type 1 AIP was achieved by most observers in > 60% of the cases, the confidence levels varied. Because some ambiguities exist, the histological diagnostic levels based on the diagnostic criteria of type 1 AIP should not be taken for granted. Guidance is effective for improving accurate PDAC diagnoses (notably by recognizing acinar-ductal metaplasia) and for evaluating storiform fibrosis.

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Data availability

The datasets generated and/or analyzed during this study are available from the corresponding author on reasonable request.

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Funding

This work was supported by MHLW Research Program on Rare and Intractable Diseases Grant Number JPMH20FC1040.

Author information

Authors and Affiliations

  1. Department of Anatomic Pathology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, 710-8602, Japan

    Kenji Notohara

  2. Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan

    Terumi Kamisawa

  3. Department of Investigative Pathology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Toru Furukawa

  4. Department of Pathology, Jichi Medical University, Shimotsuke, Japan

    Noriyoshi Fukushima

  5. Department of Laboratory Medicine, Shinshu University School of Medicine, Matsumoto, Japan

    Takeshi Uehara & Shota Kobayashi

  6. Department of Clinical Laboratory Science, Graduate School of Health Science, Kanazawa University, Kanazawa, Japan

    Satomi Kasashima

  7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

    Eisuke Iwasaki

  8. Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Atsushi Kanno

  9. Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan

    Atsushi Kanno

  10. Department of Diagnostic Pathology, National Hospital Organization Kanazawa Medical Center, Kanazawa, Japan

    Atsuhiro Kawashima

  11. Depatment of Endoscopy, Yokohama City University Hospital, Yokohama, Japan

    Kensuke Kubota

  12. Department of Gastroenterology, Shinshu University School of Medicine, Matsumoto, Japan

    Yasuhiro Kuraishi

  13. Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan

    Masayo Motoya

  14. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

    Itaru Naitoh

  15. Department of Gastroenterology, Tokyo Women’s Medical University, Yachiyo Medical Center, Yachiyo, Japan

    Takayoshi Nishino

  16. Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Junichi Sakagami

  17. Fukuchiyama City Hospital, Fukuchiyama, Japan

    Junichi Sakagami

  18. Department of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan

    Kyoko Shimizu

  19. Department of Gastroenterology, Kyoto University Hospital, Kyoto, Japan

    Teruko Tomono

  20. Department of Pathology and Microbiology, Faculty of Medicine, Saga University, Saga, Japan

    Shinichi Aishima

  21. Department of Human Pathology, Juntendo University School of Medicine, Tokyo, Japan

    Yuki Fukumura & Sho Tsuyama

  22. Department of Pathology, Tokai University School of Medicine, Isehara, Japan

    Kenichi Hirabayashi & Masashi Miyaoka

  23. Division of Pathology, Research Center for Innovative Oncology, National Cancer Center, Kashiwa, Japan

    Motohiro Kojima

  24. Department of Surgical Pathology, Hokkaido University Hospital, Sapporo, Japan

    Tomoko Mitsuhashi

  25. Department of Diagnostic Pathology, Kurume University Hospital, Kurume, Japan

    Yoshiki Naito

  26. Department of Pathology, Showa University Fujigaoka Hospital, Yokohama, Japan

    Nobuyuki Ohike

  27. Division of Pathology, Shizuoka Cancer Center, Sunto-gun, Japan

    Nobuyuki Ohike

  28. Department of Diagnostic Pathology, Tokai University Hachioji Hospital, Hachioji, Japan

    Takuma Tajiri

  29. Department of Pathology, Saitama Medical University, Saitama, Japan

    Hiroshi Yamaguchi

  30. Department of Pathology, Kawasaki Medical School, Kurashiki, Japan

    Hideyo Fujiwara

  31. Department of Diagnostic Pathology, Kagawa University, Kita-gun, Japan

    Emi Ibuki

  32. Department of Organ Pathology, Faculty of Medicine, Shimane University, Izumo, Japan

    Mamiko Nagase

  33. Department of Pathology, Kochi Medical School, Kochi University, Nangoku, Japan

    Junko Nakashima

  34. Department of Pathology, Kurume University School of Medicine, Kurume, Japan

    Masamichi Nakayama

  35. Department of Diagnostic Pathology, Tottori Prefectural Central Hospital, Tottori, Japan

    Shinsuke Oda

  36. Molecular Pathology, Hiroshima University, Hiroshima, Japan

    Daiki Taniyama

  37. Tokushima Red Cross Hospital, Tokushima, Japan

    Syunsuke Watanabe

  38. Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan

    Tsukasa Ikeura

  39. Department of Internal Medicine, Matsumoto Dental University, Shiojiri, Japan

    Shigeyuki Kawa

  40. Kansai Medical University Kouri Hospital, Neyagawa, Japan

    Kazuichi Okazaki

Authors
  1. Kenji Notohara
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  2. Terumi Kamisawa
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  3. Toru Furukawa
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  4. Noriyoshi Fukushima
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  5. Takeshi Uehara
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  6. Satomi Kasashima
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  7. Eisuke Iwasaki
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  8. Atsushi Kanno
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  9. Atsuhiro Kawashima
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  10. Kensuke Kubota
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  11. Yasuhiro Kuraishi
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  12. Masayo Motoya
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  13. Itaru Naitoh
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  14. Takayoshi Nishino
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  15. Junichi Sakagami
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  16. Kyoko Shimizu
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  17. Teruko Tomono
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  18. Shinichi Aishima
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  19. Yuki Fukumura
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  20. Kenichi Hirabayashi
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  21. Motohiro Kojima
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  22. Tomoko Mitsuhashi
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  23. Yoshiki Naito
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  24. Nobuyuki Ohike
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  25. Takuma Tajiri
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  26. Hiroshi Yamaguchi
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  27. Hideyo Fujiwara
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  28. Emi Ibuki
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  29. Shota Kobayashi
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  30. Masashi Miyaoka
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  31. Mamiko Nagase
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  32. Junko Nakashima
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  33. Masamichi Nakayama
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  34. Shinsuke Oda
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  35. Daiki Taniyama
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  36. Sho Tsuyama
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  37. Syunsuke Watanabe
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  38. Tsukasa Ikeura
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  39. Shigeyuki Kawa
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  40. Kazuichi Okazaki
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Contributions

K. Notohara, T. Kamisawa, T. Ikeura, S. Kawa, and K. Okazaki conceived and designed the study. K. Notohara, T. Furukawa, N. Fukushima, T. Tajiri, and H. Yamaguchi drafted the guidance as working group members. E. Iwasaki, A. Kanno, A. Kawashima, K. Kubota, Y. Kuraishi, M. Motoya, I. Naitoh, T. Nishino, J. Sakagami, K. Shimizu, and T. Tomono contributed the specimens and collected and analyzed the clinical data. T. Uehara, S. Kasashima, S. Aishima, Y. Fukumura, K. Hirabayashi, M. Kojima, T. Mitsuhashi, Y. Naito, N. Ohike, H. Fujiwara, E. Ibuki, S. Kobayashi, M. Miyaoka, M. Nagase, J. Nakashima, M. Nakayama, S. Oda, D. Taniyama, S. Tsuyama, and S. Watanabe participated in the interobserver agreement studies. All of the authors critically reviewed the drafts and approved the manuscript’s final version.

Corresponding author

Correspondence to Kenji Notohara.

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Ethics approval

This study was approved by the Ethical Review Boards of Kansai Medical University, Kurashiki Central Hospital, and all of the institutes that provided histological samples.

Consent to participate

Because this was a retrospective study, the acquisition of patients’ informed consent was waived, but an opt-out policy was used.

Conflict of interest

The authors declare no competing interests.

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Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 17 KB)

Supplementary file2 (XLSX 12 KB)

428_2021_3236_MOESM3_ESM.docx

Supplementary file3 Summary of the guidance for diagnosing autoimmune pancreatitis based on biopsy specimens (DOCX 18 KB)

Supplementary file4 Flow diagrams of the case selection and interobserver agreement study (PDF 103 KB)

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Supplementary file5 The ratio of the definite histological diagnostic levels and the confidence levels of each observer. The heights of the bars indicate the ratios of cases with a definite histological diagnosis by each observer. Each bar is colored with the confidence levels for each observer. Note that some observers felt that no cases were definitely diagnostic (no blue portions) even though the histological diagnostic level was definite. In round 2, the confidence levels increased among the specialists but were not much different from the round 1 confidence levels among the generalists (JPG 539 KB)

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Notohara, K., Kamisawa, T., Furukawa, T. et al. Concordance of the histological diagnosis of type 1 autoimmune pancreatitis and its distinction from pancreatic ductal adenocarcinoma with endoscopic ultrasound-guided fine needle biopsy specimens: an interobserver agreement study. Virchows Arch 480, 565–575 (2022). https://doi.org/10.1007/s00428-021-03236-w

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  • DOI: https://doi.org/10.1007/s00428-021-03236-w

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