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Kato S, Kuwatani M, Onodera M, et al. Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2021;doi: 10.1016/j.cgh.2021.08.016.
Kato, S., Kuwatani, M., Onodera, M., Kudo, T., Sano, I., Katanuma, A., Uebayashi, M., Eto, K., Fukasawa, M., Hashigo, S., Iwashita, T., Yoshida, M., Taya, Y., Kawakami, H., Kato, H., Nakai, Y., Kobashigawa, K., Kawahata, S., Shinoura, S., Ito, K., Kubo, K., Yamato, H., Hara, K., Maetani, I., Mukai, T., Shibukawa, G., & Itoi, T. (2021). Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, . https://doi.org/10.1016/j.cgh.2021.08.016
Kato, Shin, et al. "Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial." Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association vol. (2021). doi: https://doi.org/10.1016/j.cgh.2021.08.016
Kato S, Kuwatani M, Onodera M, Kudo T, Sano I, Katanuma A, Uebayashi M, Eto K, Fukasawa M, Hashigo S, Iwashita T, Yoshida M, Taya Y, Kawakami H, Kato H, Nakai Y, Kobashigawa K, Kawahata S, Shinoura S, Ito K, Kubo K, Yamato H, Hara K, Maetani I, Mukai T, Shibukawa G, Itoi T. Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2021 Aug 13; doi: 10.1016/j.cgh.2021.08.016. Epub 2021 Aug 13. PMID: 34391923.
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Clin Gastroenterol Hepatol. 2021 Aug 13; doi: 10.1016/j.cgh.2021.08.016. Epub 2021 Aug 13.

Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Shin Kato, Masaki Kuwatani, Manabu Onodera, Taiki Kudo, Itsuki Sano, Akio Katanuma, Minoru Uebayashi, Kazunori Eto, Mitsuharu Fukasawa, Shunpei Hashigo, Takuji Iwashita, Makoto Yoshida, Yoko Taya, Hiroshi Kawakami, Hironari Kato, Yousuke Nakai, Kasen Kobashigawa, Shuhei Kawahata, Susumu Shinoura, Kei Ito, Kimitoshi Kubo, Hiroaki Yamato, Kazuo Hara, Iruru Maetani, Tsuyoshi Mukai, Goro Shibukawa, Takao Itoi

Affiliations

  1. Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
  2. Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan; Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan. Electronic address: [email protected].
  3. Department of Gastroenterology, NTT Medical Center Sapporo Hospital, Sapporo, Japan.
  4. Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.
  5. Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan.
  6. Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
  7. Department of Gastroenterology, Kitami Red Cross Hospital, Kitami, Japan.
  8. Department of Gastroenterology, Tomakomai Municipal Hospital, Tomakomai, Japan.
  9. First Department of Internal Medicine, University of Yamanashi, Chuo, Japan.
  10. Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
  11. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
  12. Department of Medical Oncology, Sapporo Medical University Hospital, Sapporo, Japan.
  13. Department of Gastroenterology, NHO Hokkaido Medical Center, Sapporo, Japan.
  14. Department of Gastroenterology, University of Miyazaki Hospital, Miyazaki, Japan.
  15. Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan.
  16. Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital, Tokyo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
  17. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Gastroenterology, Urasoe General Hospital, Urasoe, Japan.
  18. Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan.
  19. Department of Gastroenterology, Okinawa Prefectural Chubu Hospital, Uruma, Japan.
  20. Department of Gastroenterology, Sendai Open Hospital, Sendai, Japan.
  21. Department of Gastroenterology, NHO Hakodate Hospital, Hakodate, Japan.
  22. Department of Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.
  23. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
  24. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
  25. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
  26. Department of Gastroenterology, Fukushima Medical University, Aizu Medical Center, Aizu, Japan.
  27. Department of Gastroenterology, Tokyo Medical University Hospital, Tokyo, Japan.

PMID: 34391923 DOI: 10.1016/j.cgh.2021.08.016

Abstract

BACKGROUND & AIMS: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP.

METHODS: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement.

RESULTS: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups.

CONCLUSION: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm.

Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.

Keywords: Biliary Drainage; Biliary Stricture; Endoscopic Sphincterotomy; Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis

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