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Comparison between ulinastatin and gabexate mesylate for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective, randomized trial

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Abstract

Background

It has been reported that the administration of ulinastatin, gabexate mesylate, or somatostatin may be effective in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, few randomized trials of ulinastatin and gabexate mesylate for the prevention of post-ERCP pancreatitis have been reported. The aim of this study was to compare the efficacy of ulinastatin and gabexate mesylate for the prevention of post-ERCP pancreatitis.

Methods

Sixty-eight patients who underwent diagnostic ERCP at our hospital were divided at random by computer-generated randomization into an ulinastatin group (n = 34) and a gabexate group (n = 34). Each patient received a continuous intravenous infusion of ulinastatin (150 000 units) or gabexate mesylate (600 mg), beginning 60–90 min before the ERCP and continuing until 22 h after the ERCP. The primary endpoint was the incidence of post-ERCP pancreatitis, and the secondary endpoints were the incidences of hyperenzymemia and pain.

Results

The overall incidence of post-ERCP pancreatitis was 2.9% (two patients), comprising one patient in the ulinastatin group and one patient in the gabexate group (2.9% vs 2.9%, respectively). Neither of these two patients developed severe pancreatitis. There were no significant differences in the serum levels of pancreatic enzymes or in the levels of pain between the two groups.

Conclusions

There was no clinical difference between the effect of preventive administration of ulinastatin and that of gabexate mesylate on the incidence of post-ERCP pancreatitis. Ulinastatin may be equivalent in efficacy to gabexate for reducing the incidence of post-ERCP pancreatitis.

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References

  1. T Yamamoto M Mori H Mimura K Hamazaki H Kashino A Gouchi et al. (1991) ArticleTitleEffects of gabexate mesylate (FOY) on the gallbladder, sphincter of Oddi and duodenum of the normal and gastrectomized dogs (abstract in English) J Smooth Muscle Res 27 87–96

    Google Scholar 

  2. V Di Francesco A Mariani G Angelini E Masci L Frulloni G Talamini et al. (2002) ArticleTitleEffects of gabexate mesylate, a protease inhibitor, on human sphincter of Oddi motility Dig Dis Sci 47 741–5 Occurrence Handle11991602 Occurrence Handle10.1023/A:1014775513616 Occurrence Handle1:CAS:528:DC%2BD38XjvFGntLw%3D

    Article  PubMed  CAS  Google Scholar 

  3. G Cavallini A Tittobello L Frulloni E Masci A Mariani V Di Francesco et al. (1996) ArticleTitleGabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography N Engl J Med 335 913–23 Occurrence Handle10.1056/NEJM199609263351302

    Article  Google Scholar 

  4. A Andriulli G Leandro G Niro A Mangia V Festa G Gambassi et al. (2000) ArticleTitlePharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis Gastrointest Endosc 51 1–7 Occurrence Handle10625786 Occurrence Handle10.1016/S0016-5107(00)70377-4 Occurrence Handle1:STN:280:DC%2BD3c%2Fpt1OrtA%3D%3D

    Article  PubMed  CAS  Google Scholar 

  5. E Masci G Cavallini A Mariani L Frulloni PA Testoni S Curioni et al. (2003) ArticleTitleComparison of two dosing regimens of gabexate in the prophylaxis of post-ERCP pancreatitis Am J Gastroenterol 98 2182–6 Occurrence Handle14572565 Occurrence Handle10.1111/j.1572-0241.2003.07698.x Occurrence Handle1:CAS:528:DC%2BD3sXot12itrc%3D

    Article  PubMed  CAS  Google Scholar 

  6. GS Xing SM Wu XW Zhang ZZ Ge (2006) ArticleTitleClinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis Braz J Med Biol Res 39 85–90

    Google Scholar 

  7. T Tsujino Y Komatsu H Isayama K Hirano N Sosohiro N Yamamoto et al. (2005) ArticleTitleUlinastatin for pancreatitis after endoscopic retrograde cholangiopancreatography: a randomized, controlled trial Clin Gastroenterol Hepatol 3 376–83 Occurrence Handle15822043 Occurrence Handle10.1016/S1542-3565(04)00671-8 Occurrence Handle1:CAS:528:DC%2BD2MXktVSisrw%3D

    Article  PubMed  CAS  Google Scholar 

  8. H Fujishiro K Adachi T Imaoka T Hashimoto N Kohge N Moriyama et al. (2006) ArticleTitleUlinastatin shows preventive effect on post-endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study J Gastroenterol Hepatol 21 1065–9 Occurrence Handle16724996 Occurrence Handle10.1111/j.1440-1746.2006.04085.x Occurrence Handle1:CAS:528:DC%2BD28XntVylur8%3D

    Article  PubMed  CAS  Google Scholar 

  9. SY Chen JY Wang (2001) ArticleTitleUlinastatin in the treatment of acute pancreatitis: a multicenter clinical trial Chin J Dig Dis 21 293–6

    Google Scholar 

  10. PA Testoni F Bagnolo (2001) ArticleTitlePain at 24 h associated with amylase levels greater than 5 times the upper normal limit as the most reliable indicator of post-ERCP pancreatitis Gastrointest Endosc 53 33–9 Occurrence Handle11154486 Occurrence Handle10.1067/mge.2001.111390 Occurrence Handle1:STN:280:DC%2BD3M3gt1ehsw%3D%3D

    Article  PubMed  CAS  Google Scholar 

  11. PB Cotton G Lehman J Vennes JE Geenen RCG Russell WC Meyers et al. (1991) ArticleTitleEndoscopic sphincterotomy complications and their management: an attempt at consensus Gastrointest Endosc 37 383–93 Occurrence Handle2070995 Occurrence Handle1:STN:280:DyaK3MzgtFChtQ%3D%3D Occurrence Handle10.1016/S0016-5107(91)70740-2

    Article  PubMed  CAS  Google Scholar 

  12. E Kaneko H Harada T Kasugai K Ogoshi H Tanba (2004) ArticleTitleComplications from gastrointestinal endoscopy procedure from 1998 to 2002 (in Japanese) Gastroenterol Endosc 46 54–61

    Google Scholar 

  13. InstitutionalAuthorNameAmerican Society for Gastrointestinal Endoscopy (2003) ArticleTitleComplications of ERCP Gastrointest Endosc 57 633–8 Occurrence Handle10.1053/ge.2003.v57.amge030576633

    Article  Google Scholar 

  14. T Otani (1998) ArticleTitleSynthetic protease inhibitor for human acute pancreatitis (in Japanese) Nippon Shokakibyo Gakkai Zasshi 95 1205–11 Occurrence Handle9852723 Occurrence Handle1:STN:280:DyaK1M%2FmvFyhtw%3D%3D

    PubMed  CAS  Google Scholar 

  15. S Takasugi N Toki (1980) ArticleTitleInhibitory effects of native and synthetic protease inhibitors on plasma proteases in acute pancreatitis Hiroshima J Med Sci 29 189–94 Occurrence Handle7009505 Occurrence Handle1:CAS:528:DyaL3MXhvVGntrs%3D

    PubMed  CAS  Google Scholar 

  16. J Hirose T Ozawa T Miura M Isaji Y Nagao K Yamashiro et al. (1998) ArticleTitleHuman neutrophil elastase degrades inter-α-trypsin inhibitor to liberate urinary trypsin inhibitor related proteins Biol Pharm Bull 21 651–6 Occurrence Handle9703243 Occurrence Handle1:CAS:528:DyaK1cXkslyjtbc%3D

    PubMed  CAS  Google Scholar 

  17. A Andriulli L Solmi S Loperfido P Leo V Festa A Belmonte et al. (2004) ArticleTitleProphylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate Clin Gastroenterol Hepatol 2 713–8 Occurrence Handle15290665 Occurrence Handle10.1016/S1542-3565(04)00295-2 Occurrence Handle1:CAS:528:DC%2BD2cXnt1OisLg%3D

    Article  PubMed  CAS  Google Scholar 

  18. J Devière OL Moine JL Van Laethem P Eisendrath A Ghilain N Severs et al. (2001) ArticleTitleInterleukin 10 reduces the incidence of pancreatitis after therapeutic endoscopic retrograde cholangiopancreatography Gastroenterology 120 498–505 Occurrence Handle11159890 Occurrence Handle10.1053/gast.2001.21172

    Article  PubMed  Google Scholar 

  19. B Murray R Carter C Imrie S Evans C O'Suilleabhain (2003) ArticleTitleDiclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography Gastroenterology 124 1786–91 Occurrence Handle12806612 Occurrence Handle10.1016/S0016-5085(03)00384-6 Occurrence Handle1:CAS:528:DC%2BD3sXlt1yrt7c%3D

    Article  PubMed  CAS  Google Scholar 

  20. RT Poon C Yeung CL Liu CM Lam WK Yuen CM Lo et al. (2003) ArticleTitleIntravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomized controlled trial Gut 52 1768–73 Occurrence Handle14633959 Occurrence Handle10.1136/gut.52.12.1768 Occurrence Handle1:CAS:528:DC%2BD2cXhtlSgug%3D%3D

    Article  PubMed  CAS  Google Scholar 

  21. H Messmann W Vogt A Holstege G Lock A Heinisch A von Fürstenberg et al. (1997) ArticleTitlePost-ERP pancreatitis as a model for cytokine induced acute phase response in acute pancreatitis Gut 40 80–5 Occurrence Handle9155580 Occurrence Handle1:STN:280:DyaK2szgtVGmuw%3D%3D

    PubMed  CAS  Google Scholar 

  22. I Honjyo K Ishii T Sato Y Goto S Naito R Mizumoto et al. (1984) ArticleTitleUsefulness of MR-20 in pancreatitis: a multicenter prospective randomized study (in Japanese) Igaku No Ayumi 129 70–83

    Google Scholar 

  23. A Saluja M Saluja A Villa U Leli P Rutledge J Meldolesi et al. (1989) ArticleTitlePancreatic duct obstruction in rabbits causes digestive zymogen and lysosomal enzyme colocalization J Clin Invest 84 1260–6 Occurrence Handle2477393 Occurrence Handle1:CAS:528:DyaL1MXlvFamsrk%3D Occurrence Handle10.1172/JCI114293

    Article  PubMed  CAS  Google Scholar 

  24. ML Freeman DB Nelson S Sherman GB Haber ME Herman PJ Dorsher et al. (1996) ArticleTitleComplication of endoscopic biliary sphincterotomy N Engl J Med 335 909–18 Occurrence Handle8782497 Occurrence Handle10.1056/NEJM199609263351301 Occurrence Handle1:STN:280:DyaK28zmsFaktw%3D%3D

    Article  PubMed  CAS  Google Scholar 

  25. S Loperfido G Angelini G Benedetti F Chilovi F Costan F DeBerardinis et al. (1998) ArticleTitleMajor early complications from diagnostic and therapeutic ERCP: a prospective multicenter study Gastrointest Endosc 48 1–10 Occurrence Handle9684657 Occurrence Handle10.1016/S0016-5107(98)70121-X Occurrence Handle1:STN:280:DyaK1czkslOquw%3D%3D

    Article  PubMed  CAS  Google Scholar 

  26. E Masci G Toti A Mariani S Curioni A Lomazzi M Dinelli et al. (2001) ArticleTitleComplications of diagnostic and therapeutic ERCP: a prospective multicenter study Am J Gastroenterol 96 417–23 Occurrence Handle11232684 Occurrence Handle10.1111/j.1572-0241.2001.03594.x Occurrence Handle1:STN:280:DC%2BD3M7ot12gsQ%3D%3D

    Article  PubMed  CAS  Google Scholar 

  27. ML Freeman JA DiSario DB Nelson MB Fennerty JG Lee DJ Bjorkman et al. (2001) ArticleTitleRisk factors for post-ERCP pancreatitis: a prospective, multicenter study Gastrointest Endosc 54 425–34 Occurrence Handle11577302 Occurrence Handle10.1067/mge.2001.117550 Occurrence Handle1:STN:280:DC%2BD3Mrlt1CisA%3D%3D

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Department of Gastroenterology, Chikushi Hospital, Fukuoka University, 1-1-1 Zokumyoin, Chikushino-shi, Fukuoka, 818-8502, Japan

    Toshiharu Ueki, Keisuke Otani, Kenichiro Kawamoto, Aiko Shimizu, Naruhito Fujimura, Seigo Sakaguchi & Toshiyuki Matsui

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  1. Toshiharu Ueki
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  2. Keisuke Otani
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  3. Kenichiro Kawamoto
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  4. Aiko Shimizu
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  5. Naruhito Fujimura
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  6. Seigo Sakaguchi
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  7. Toshiyuki Matsui
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Ueki, T., Otani, K., Kawamoto, K. et al. Comparison between ulinastatin and gabexate mesylate for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective, randomized trial. J Gastroenterol 42, 161–167 (2007). https://doi.org/10.1007/s00535-006-1986-8

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  • DOI: https://doi.org/10.1007/s00535-006-1986-8

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