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Continuous regional arterial infusion versus intravenous administration of the protease inhibitor nafamostat mesilate for predicted severe acute pancreatitis: a multicenter, randomized, open-label, phase 2 trial.

Authors
  • Hirota, Morihisa1
  • Shimosegawa, Tooru2
  • Kitamura, Katsuya3, 4
  • Takeda, Kazunori5
  • Takeyama, Yoshifumi6
  • Mayumi, Toshihiko7
  • Ito, Tetsuhide8
  • Takenaka, Mamoru9
  • Iwasaki, Eisuke10
  • Sawano, Hirotaka11
  • Ishida, Etsuji12
  • Miura, Shin13
  • Masamune, Atsushi13
  • Nakai, Yousuke14, 15
  • Mitoro, Akira16
  • Maguchi, Hiroyuki17
  • Kimura, Kenji18
  • Sanuki, Tsuyoshi19
  • Ito, Tetsuya20, 21
  • Haradome, Hiroki22
  • And 9 more
  • 1 Division of Gastroenterology and Hepatology, Tohoku Medical and Pharmaceutical University, 1-15-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, 9838536, Japan. [email protected] , (Japan)
  • 2 Department of Gastroenterology, South Miyagi Medical Center, 28-1 Nishi, Ohgawara, Miyagi, 9891253, Japan. , (Japan)
  • 3 Division of Gastroenterology, Department of Medicine, Showa University School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 1428666, Japan. , (Japan)
  • 4 Department of Gastroenterology and Hepatology, Tokyo Medical University Hachioji Medical Center, 1163, Tatemachi, Hachioji-Shi, Tokyo, 1930998, Japan. , (Japan)
  • 5 Miyagi Branch, Health Insurance Claims Review & Reimbursement Services, 5-1-27, Tsutsujigaoka, Miyagino-ku, Sendai, Miyagi, 9838504, Japan. , (Japan)
  • 6 Department of Surgery, Kindai University, Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 5898511, Japan. , (Japan)
  • 7 Department of Emergency Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, 8078555, Japan. , (Japan)
  • 8 Department of Gastroenterology and Hepatology, International University of Health and Welfare Graduate School of Medicine, Neuroendocrine Tumor Center, Fukuoka Sanno Hospital, 3-6-45, Momochihama, Sawara-ku, Fukuoka, 8140001, Japan. , (Japan)
  • 9 Department of Gastroenterology and Hepatology, Kindai University, Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 5898511, Japan. , (Japan)
  • 10 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 1608582, Japan. , (Japan)
  • 11 Senri Critical Care Medical Center, Osaka Saiseikai Senri Hospital, 1-1-6, Tsukumodai, Suita, Osaka, 5650862, Japan. , (Japan)
  • 12 Department of Gastroenterology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, 7108602, Japan. , (Japan)
  • 13 Division of Gastroenterology, Tohoku University Graduate School of Medicine, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan. , (Japan)
  • 14 Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. , (Japan)
  • 15 Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 1138655, Japan. , (Japan)
  • 16 Third Department of Internal Medicine, Nara Medical University, 840, Shijo-cho, Kashihara, Nara, 6348522, Japan. , (Japan)
  • 17 Center for Gastroenterology, Teine-keijinkai Hospital, 1-12-1-40, Maeda, Teine-ku, Sapporo, 0068555, Japan. , (Japan)
  • 18 Department of Gastroenterology, National Hospital Organization Sendai Medical Center, 2-11-12, Miyagino, Miyagino-ku, Sendai, Miyagi, 9838520, Japan. , (Japan)
  • 19 Department of Gastroenterology, Kita-Harima Medical Center, 926-250, Ichiba-cho, Ono, Hyogo, 6751392, Japan. , (Japan)
  • 20 Department of Internal Medicine, Gastroenterology, Shinshu University Hospital, 3-1-1, Akashi, Matsumoto, Nagano, 3908621, Japan. , (Japan)
  • 21 Division of Gastroenterology, Nagano Red Cross Hospital, 5-22-1, Wakasato, Nagano, 3808582, Japan. , (Japan)
  • 22 Department of Radiological Advanced Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 2520375, Japan. , (Japan)
  • 23 Department of Radiology, Kanazawa University, Graduate School of Medical Sciences, 13-1, Takaramachi, Kanazawa, Ishikawa, 9208641, Japan. , (Japan)
  • 24 Department of Gastroenterology, Otsu Municipal Hospital, 2-9-9, Motomiya, Otsu, Shiga, 5200804, Japan. , (Japan)
  • 25 Department of Surgery, Kumamoto Regional Medical Center, 5-16-10, Honjou, Chuou-ku, Kumamoto, 8600811, Japan. , (Japan)
  • 26 Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Graduate School of Medicine, 2-174, Edobashi, Tsu, Mie, 5148507, Japan. , (Japan)
  • 27 Inter Scientific Research Co., Ltd, 3-14-1, Higashinakano, Nakano-ku, Tokyo, 1640003, Japan. , (Japan)
  • 28 Department of Development Promotion, Clinical Research, Innovation, Education Center, Tohoku University Hospital, 1-1, Seiryo, Aoba-ku, Sendai, Miyagi, 9808574, Japan. , (Japan)
Type
Published Article
Journal
Journal of gastroenterology
Publication Date
Mar 01, 2020
Volume
55
Issue
3
Pages
342–352
Identifiers
DOI: 10.1007/s00535-019-01644-z
PMID: 31758329
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Continuous regional arterial infusion (CRAI) of protease inhibitor nafamostat mesilate (NM) is used in the context of predicted severe acute pancreatitis (SAP) to prevent the development of pancreatic necrosis. Although this therapy is well known in Japan, its efficacy and safety remain unclear. This investigator-initiated and -driven, multicenter, open-label, randomized, controlled trial (UMIN000020868) enrolled 39 patients with predicted SAP and low enhancement of the pancreatic parenchyma on computed tomography (CT). Twenty patients were assigned to the CRAI group, while 19 served as controls and were administered NM at the same dose intravenously (IV group). The primary endpoint was the development of pancreatic necrosis as determined by CT on Day 14, judged by blinded central review. There was no difference between the CRAI and IV groups regarding the percentages of participants who developed pancreatic necrosis (more than 1/3 of the pancreas: 25.0%, range 8.7-49.1% vs. 15.8%, range 3.4-39.6%, respectively, P = 0.694; more than 2/3 of the pancreas: 20%, range 5.7-43.7% vs. 5.3%, range 0.1-26.0%, respectively, P = 0.341). The early analgesic effect was evaluated based on 24-h cumulative fentanyl consumption and additional administration by intravenous patient-controlled analgesia. The results showed that the CRAI group used significantly less analgesic. There were two adverse events related to CRAI, namely bleeding and splenic infarction. CRAI with NM did not inhibit the development of pancreatic necrosis although early analgesic effect of CRAI was superior to that of IV. Less-invasive IV therapy can be considered a viable alternative to CRAI therapy.

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