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Ulinastatin shows preventive effect on post‐endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study
Author(s) -
Fujishiro Hirofumi,
Adachi Kyoichi,
Imaoka Tomonori,
Hashimoto Tomoyuki,
Kohge Naruaki,
Moriyama Nobuyuki,
Suetsugu Hiroshi,
Kawashima Kousaku,
Komazawa Yoshinori,
Ishimura Norihisa,
Ishihara Shunji,
Amano Yuji,
Kinoshita Yoshikazu
Publication year - 2006
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2006.04085.x
Subject(s) - ulinastatin , medicine , hyperamylasemia , endoscopic retrograde cholangiopancreatography , pancreatitis , gastroenterology , acute pancreatitis , prospective cohort study , surgery , amylase , biochemistry , chemistry , enzyme
Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) is a useful diagnostic and therapeutic procedure; however, ERCP occasionally causes post‐ERCP pancreatitis. The administration of gabexate mesilate has been reported to be effective for the prevention for post‐ERCP pancreatitis when given during and after the procedure. The aim of the present study was to investigate the preventive effect of the novel protease inhibitor ulinastatin on post‐ERCP pancreatitis. Methods: One hundred and thirty‐nine patients who underwent the ERCP procedure were studied. These patients were randomly divided into three groups based on the agent and dose given during and following the ERCP procedure: gabexate mesilate (900 mg), high‐dose ulinastatin (450 000 units) and low‐dose ulinastatin (150 000 units). Serum amylase, interleukin (IL)‐6 and IL‐8 levels and plasma polymorphonuclear leukocyte elastase (PMN‐E) activity were measured after ERCP. In addition, post‐ERCP hyperamylasemia and post‐ERCP pancreatitis were recorded. Results: There were no significant differences in serum amylase, IL‐6 and IL‐8 levels and PMN‐E activity after ERCP procedure between the three groups. Post‐ERCP pancreatitis was observed in two (4.3%), three (6.5%) and four (8.5%) cases in the gabexate mesilate, high‐dose ulinastatin and low‐dose ulinastatin groups, respectively. Multiple logistic regression analysis showed that the addition of endoscopic sphincterotomy during the ERCP procedure was the only significant risk factor for the development of post‐ERCP hyperamylasemia and post‐ERCP pancreatitis ( P = 0.03 and P = 0.04, respectively), but there was no significant difference in the occurrence of post‐ERCP hyperamylasemia and post‐ERCP pancreatitis between the three groups receiving different preventative treatments. Conclusion: The administration of low‐ and high‐dose ulinastatin has similar effects to high‐dose gabexate in the prevention of post‐ERCP pancreatitis.