title: Ulinastatin shows preventive effect on post-endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The administration of low- and high-dose ulinastatin has similar effects to high-dose gabexate in the prevention of post-ERCP pancreatitis.
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujishiro
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Adachi
authors.forename: Tomonori
authors.initials: T
authors.lastname: Imaoka
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Hashimoto
authors.forename: Naruaki
authors.initials: N
authors.lastname: Kohge
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Moriyama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Suetsugu
authors.forename: Kousaku
authors.initials: K
authors.lastname: Kawashima
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Komazawa
authors.forename: Norihisa
authors.initials: N
authors.lastname: Ishimura
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.forename: Yuji
authors.initials: Y
authors.lastname: Amano
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
mesh_terms: D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D006023:Glycoproteins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D014361:Trypsin Inhibitors / Q000627:therapeutic use*
chemical_list: D006023:Glycoproteins; D014361:Trypsin Inhibitors; C028665:urinastatin