TOKYO criteria 2024 for the assessment of clinical outcomes of endoscopic biliary drainage

Author:

Isayama Hiroyuki1ORCID,Hamada Tsuyoshi23ORCID,Fujisawa Toshio1ORCID,Fukasawa Mitsuharu4,Hara Kazuo5ORCID,Irisawa Atsushi6ORCID,Ishii Shigeto1,Ito Ken7ORCID,Itoi Takao8ORCID,Kanno Yoshihide9ORCID,Katanuma Akio10ORCID,Kato Hironari11ORCID,Kawakami Hiroshi12ORCID,Kawamoto Hirofumi13,Kitano Masayuki14ORCID,Kogure Hirofumi15ORCID,Matsubara Saburo16ORCID,Mukai Tsuyoshi17,Naitoh Itaru18ORCID,Ogura Takeshi1920ORCID,Ryozawa Shomei21ORCID,Sasaki Takashi3,Shimatani Masaaki22,Shiomi Hideyuki23ORCID,Sugimori Kazuya24,Takenaka Mamoru25ORCID,Yasuda Ichiro26ORCID,Nakai Yousuke227ORCID,Fujita Naotaka28,Inui Kazuo29,

Affiliation:

1. Department of Gastroenterology, Graduate School of Medicine Juntendo University Tokyo Japan

2. Department of Gastroenterology, Graduate School of Medicine The University of Tokyo Tokyo Japan

3. Department of Hepato‐Biliary‐Pancreatic Medicine Cancer Institute Hospital, Japanese Foundation for Cancer Research Tokyo Japan

4. Department of Gastroenterology Japan Community Health Care Organization Yamanashi Hospital Yamanashi Japan

5. Department of Gastroenterology Aichi Cancer Center Hospital Aichi Japan

6. Department of Gastroenterology Dokkyo Medical University School of Medicine Tochigi Japan

7. Division of Gastroenterology and Hepatology, Department of Internal Medicine Toho University Ohashi Medical Center Tokyo Japan

8. Department of Gastroenterology and Hepatology Tokyo Medical University Tokyo Japan

9. Department of Gastroenterology Sendai City Medical Center Miyagi Japan

10. Center for Gastroenterology Teine Keijinkai Hospital Hokkaido Japan

11. Department of Gastroenterology and Hepatology Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan

12. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine University of Miyazaki Miyazaki Japan

13. Department of General Internal Medicine 2 Kawasaki Medical School General Medical Center Okayama Japan

14. Second Department of Internal Medicine Wakayama Medical University Wakayama Japan

15. Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine Tokyo Japan

16. Department of Gastroenterology and Hepatology, Saitama Medical Center Saitama Medical University Saitama Japan

17. Department of Gastroenterological Endoscopy Kanazawa Medical University Ishikawa Japan

18. Department of Gastroenterology and Metabolism Nagoya City University Graduate School of Medical Sciences Aichi Japan

19. Endoscopy Center Osaka Medical and Pharmaceutical University Osaka Japan

20. Second Department of Internal Medicine Osaka Medical and Pharmaceutical University Osaka Japan

21. Department of Gastroenterology Saitama Medical University International Medical Center Saitama Japan

22. Division of Gastroenterology and Hepatology Kansai Medical University Medical Center Osaka Japan

23. Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology Hyogo Medical University Hyogo Japan

24. Gastroenterological Center Yokohama City University Medical Center Kanagawa Japan

25. Department of Gastroenterology and Hepatology, Faculty of Medicine Kindai University Osaka Japan

26. Third Department of Internal Medicine University of Toyama Toyama Japan

27. Department of Endoscopy and Endoscopic Surgery The University of Tokyo Hospital Tokyo Japan

28. Miyagi Medical Check‐up Plaza Miyagi Japan

29. Department of Gastroenterology Yamashita Hospital Aichi Japan

Abstract

The consensus‐based TOKYO criteria were proposed as a standardized reporting system for endoscopic transpapillary biliary drainage. The primary objective was to address issues arising from the inconsistent reporting of stent outcomes across studies, which has complicated the comparability and interpretation of study results. However, the original TOKYO criteria were not readily applicable to recent modalities of endoscopic biliary drainage such as biliary drainage based on endoscopic ultrasound or device‐assisted endoscopy. There are increasing opportunities for managing hilar biliary obstruction and benign biliary strictures through endoscopic drainage. Biliary ablation has been introduced to manage benign and malignant biliary strictures. In addition, the prolonged survival times of cancer patients have increased the importance of evaluating overall outcomes during the period requiring endoscopic biliary drainage rather than solely focusing on the patency of the initial stent. Recognizing these unmet needs, a committee has been established within the Japan Gastroenterological Endoscopy Society to revise the TOKYO criteria for current clinical practice. The revised criteria propose not only common reporting items for endoscopic biliary drainage overall, but also items specific to various conditions and interventions. The term “stent‐demanding time” has been defined to encompass the entire duration of endoscopic biliary drainage, during which the overall stent‐related outcomes are evaluated. The revised TOKYO criteria 2024 are expected to facilitate the design and reporting of clinical studies, providing a goal‐oriented approach to the evaluation of endoscopic biliary drainage.

Funder

Daiichi Sankyo Company

Takeda Science Foundation

Japan Society for the Promotion of Science

Publisher

Wiley

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