Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial
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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).
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.
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.
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
KeywordsAnti-inflammatory agents Nonsteroidal ERCP Pancreatitis
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.
Grant support: University of Rijeka research Grant Number: 13.06.1.2.30.
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.
Compliance with ethical standards
Goran Hauser, Ivana Blazevic, Nermin Salkic, Goran Poropat, Vanja Giljaca, Zlatko Bulic, Davor Stimac has no conflicts of interest or financial ties to disclose.
- 4.Loperfido S, Ferrara F, Costamagna G (2015) Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. In: Post TW (ed) UpToDate. Waltham, MAGoogle Scholar
- 30.Buxbaum J, Yan A, Yeh K et al (2014) Aggressive hydration with lactated Ringer’s solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 12(303–307):e1Google Scholar
- 37.Somchai A, Tuangthip P, Pimtawan W (2009) Pain score within twenty-four hours post-therapeutic endoscopic retrograde cholangiopancreatography: a comparison between diagnostic and therapeutic procedure. Gastroenterology insights 2009, volume 1:e7, pp V1:20–3Google Scholar