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Meta-analysis and trial sequential analysis of prophylactic antibiotics for acute pancreatitis

Objectives: To evaluate the effects of prophylactic antibiotics (PAB) for AP in a meta- analysis and investigate the need for further research by trial sequential analysis (TSA). Methods: Medline, Scopus and Web of Science were searched for randomized clinical trials assessing prophylactic use of AB in AP. Primary outcomes were all infectious complications and mortality. Secondary outcomes comprised infected pancreatic necrosis (IPN) and other specific infections, organ failure, surgical interventions and length of hospital stay. TSA was performed for primary outcomes, and secondary outcomes with significant results at a level of a=0.05 and power of 80%. Risk of bias was assessed using the Cochrane tool for bias assessment. Results for dichotomous outcomes were expressed as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous results as mean differences (MDs) with 95% CIs. Results: A total of 18 trials with 1134 pts were included in the analysis. Most of trials were at high risk of bias. Overall mortality was similar in both groups (RR 0.85 ; 95% CI 0.64-1.14 ; P=0.27), but the risk for infectious complications was significantly reduced in pts receving PAB (RR 0.34 ; 95% CI 0.22-0.51 ; P<0.00001). Risks of sepsis and urinary tract infections were significantly reduced (RR 0.46 ; 95% CI 0.25-0.86 ; P=0.02)(RR 0.36 ; 95% CI 0.19-0.68 ; P=0.002), respectively, while a trend in risk reduction of IPN was shown with RR 0.78 (95% CI 0.60-1.00 ; P=0.05). There was no significant difference in risk of other infections, fungal infections, organ failure and surgical interventions. Length of hospital stay was diminished in PAB group byMD -6.65 (95% CI -8.86 to -4.43 ; P<0.00001) days. A RRR of 30% in a 10% mortality rate among controls requires sample size of 2714 pts, while the number included is 1076. A 30% RRR of 15% rate of IPN among controls requires 1725 pts, while only 959 are included so far. A 30% RRR of 30% rate of infectious complications has been achieved at 428 pts, although the estimated sample is 1923. To show a minimally relevant mean shortening of hospital stay of 3 days requires a sample size of 391 pts and according to TSA this has already been achieved at the level of 351 included pts. Conclusion: PAB clearly decrease the rate of infectious complications in AP, but mainly due to RRR of extrapancreatic infections, which requires no further research. No significant effect is shown on IPN and mortality, although firmer evidence requires additional trials and a larger sample size.

acute pancreatitis ; prophylactic antibiotics ; trial sequential analysis

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