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

• DOI: 10.1007/s00535-019-01644-z
• Publication Date: 2019-11-22T11:03:02Z
• Authors: Morihisa Hirota; Tooru Shimosegawa; Katsuya Kitamura; Kazunori Takeda; Yoshifumi Takeyama; Toshihiko Mayumi; Tetsuhide Ito; Mamoru Takenaka; Eisuke Iwasaki; Hirotaka Sawano; Etsuji Ishida; Shin Miura; Atsushi Masamune; Yousuke Nakai; Akira Mitoro; Hiroyuki Maguchi; Kenji Kimura; Tsuyoshi Sanuki; Tetsuya Ito; Hiroki Haradome; Kazuto Kozaka; Toshifumi Gabata; Keisho Kataoka; Masahiko Hirota; Shuji Isaji; Ryoji Nakamura; Koki Yamagiwa; Chie Kayaba; Koji Ikeda
• Keywords: Clinical endpoint

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