Ulinastatin shows preventive effect on post-endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study.
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.
Fujishiro
Hirofumi
H
Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan.
Adachi
Kyoichi
K
Imaoka
Tomonori
T
Hashimoto
Tomoyuki
T
Kohge
Naruaki
N
Moriyama
Nobuyuki
N
Suetsugu
Hiroshi
H
Kawashima
Kousaku
K
Komazawa
Yoshinori
Y
Ishimura
Norihisa
N
Ishihara
Shunji
S
Amano
Yuji
Y
Kinoshita
Yoshikazu
Y
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*
D006023:Glycoproteins; D014361:Trypsin Inhibitors; C028665:urinastatin