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Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial

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An Erratum to this article was published on 04 November 2016

Abstract

Background and Aims

We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

Methods

We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP.

Results

Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86–3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis.

Conclusions

The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP.

Clinical trials.gov number

NCT 01784445.

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Acknowledgments

We would like to thank the endoscopy staff and nurses working for Department of Gastroenterology in University Hospital Rijeka since without their help it would be impossible to finish this study.

Funding

Grant support: University of Rijeka research Grant Number: 13.06.1.2.30.

Authors’ contributions

GH was involved in study concept and design, acquisition of data, critical revision of the manuscript for important intellectual content, analysis and interpretation of data, and drafting the manuscript. IB was involved in acquisition of data, drafting the manuscript, and critical revision of the manuscript for important intellectual content. NS was involved in analysis and interpretation of data and statistical analysis. GP was involved in critical revision of the manuscript for important intellectual content and analysis and interpretation of data. VG was involved in acquisition of data, critical revision of the manuscript for important intellectual content, and analysis and interpretation of data. ZB was involved in acquisition of data, critical revision of the manuscript for important intellectual content, and analysis and interpretation of data. DS was involved in critical revision of the manuscript for important intellectual content, obtained funding, was involved in study supervision, and approved the final version of the manuscript.

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Authors and Affiliations

  1. Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia

    Goran Hauser, Goran Poropat, Vanja Giljača, Zlatko Bulić & Davor Štimac

  2. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia

    Goran Hauser, Goran Poropat, Vanja Giljača, Zlatko Bulić & Davor Štimac

  3. Faculty of Health Studies, University of Rijeka, Rijeka, Croatia

    Goran Hauser

  4. Department of Emergency Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia

    Ivana Blažević

  5. Department of Gastroenterology and Hepatology, University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina

    Nermin Salkić

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  1. Goran Hauser
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Corresponding author

Correspondence to Goran Hauser.

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Disclosures

Goran Hauser, Ivana Blazevic, Nermin Salkic, Goran Poropat, Vanja Giljaca, Zlatko Bulic, Davor Stimac has no conflicts of interest or financial ties to disclose.

Additional information

An erratum to this article is available at http://dx.doi.org/10.1007/s00464-016-5305-z.

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Hauser, G., Blažević, I., Salkić, N. et al. Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial. Surg Endosc 31, 602–610 (2017). https://doi.org/10.1007/s00464-016-5004-9

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