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A Double-blind, Placebo-controlled Trial of Ciprofloxacin Prophylaxis in Patients with Acute Necrotizing Pancreatitis

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

The use of prophylactic antibiotics in acute severe necrotizing pancreatitis is controversial.

Methods

Prospective, randomized, placebo-controlled, double-blind study was carried out at Bellvitge Hospital, in Barcelona, Spain. Among 229 diagnosed with severe acute pancreatitis, 80 had evidence of necrotizing pancreatitis (34/80 patients were excluded of the protocol). Forty-six patients without previous antibiotic treatment with pancreatic necrosis in a contrast-enhanced CT scan were randomly assigned to receive either intravenous ciprofloxacin or placebo. Five patients were secondarily excluded, and the remaining 41 patients were finally included in the study (22 patients received intravenous ciprofloxacin and 19 patients placebo).

Results

Comparing the 22 with intravenous ciprofloxacin and 19 with placebo, infected pancreatic necrosis was detected in 36% and 42% respectively (p = 0.7). The mortality rate was 18% and 11%, respectively (p = 0.6). No significant differences between both treatment groups were observed with respect to variables such as: non-pancreatic infections, surgical treatment, timing and the re-operation rate, organ failure, length of hospital and ICU stays.

Conclusion

The prophylactic use of ciprofloxacin in patients with severe necrotizing pancreatitis did not significantly reduce the risk of developing pancreatic infection or decrease the mortality rate. The small number of patients included in this study should be considered.

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Acknowledgments

We would like to thank the hospital pharmacy staff and nurses from the Department of Surgery for their collaboration in the study.

Author information

Authors and Affiliations

  1. Department of General Surgery and Digestive Tract, Bellvitge Hospital, Idibell, University of Barcelona, Barcelona, Spain

    A. García-Barrasa, F. G. Borobia, R. Jorba, J. Busquets & J. Fabregat

  2. Clinical Research Unit and Infectious Diseases Service, Bellvitge Hospital, Idibell, University of Barcelona, Barcelona, Spain

    R. Pallares

  3. Department of General Surgery and Digestive Tract, Hospital del Mar, Barcelona, Spain

    I. Poves

  4. Department of General Surgery and Digestive Tract, Bellvitge Hospital, C/Feixa Llarga s/n 08907, Barcelona, Spain

    J. Busquets

Authors
  1. A. García-Barrasa
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  2. F. G. Borobia
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  3. R. Pallares
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  4. R. Jorba
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  5. I. Poves
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  7. J. Fabregat
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Corresponding author

Correspondence to J. Busquets.

Additional information

This study was promoted by the “Bellvitge Hospital” and has not received any grant or payment from the pharmaceutical industry.

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García-Barrasa, A., Borobia, F.G., Pallares, R. et al. A Double-blind, Placebo-controlled Trial of Ciprofloxacin Prophylaxis in Patients with Acute Necrotizing Pancreatitis. J Gastrointest Surg 13, 768–774 (2009). https://doi.org/10.1007/s11605-008-0773-7

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  • DOI: https://doi.org/10.1007/s11605-008-0773-7

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