Ulinastatin shows preventive effect on post-endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study.

Abstract

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.

• Authors: Hirofumi Fujishiro, Kyoichi Adachi, Tomonori Imaoka, Tomoyuki Hashimoto, Naruaki Kohge, Nobuyuki Moriyama, Hiroshi Suetsugu, Kousaku Kawashima, Yoshinori Komazawa, Norihisa Ishimura, Shunji Ishihara, Yuji Amano, Yoshikazu Kinoshita
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 21 Issue 6 Pg. 1065-9 (Jun 2006) ISSN: 0815-9319 [Print] Australia
• PMID: 16724996 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Glycoproteins
• Trypsin Inhibitors
• urinastatin

Topics

• Aged
• Cholangiopancreatography, Endoscopic Retrograde (adverse effects)
• Female
• Glycoproteins (therapeutic use)
• Humans
• Male
• Middle Aged
• Pancreatitis (etiology, prevention & control)
• Trypsin Inhibitors (therapeutic use)