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This episode is our first audio journal club. We discuss 5 papers today with our guests, Dr Dan von Allmen, Dr George Whit Holcomb, and Dr Aaron Lipskar.
Use of Corticosteroids After Hepatoportoenterostomy for Bile Drainage in Infants With Biliary Atresia: the START randomized clinical trial
Discussed by Dr Dan von Allmen
Bezerra JA, Spino C, Magee JC, Shneider BL, Rosenthal P, Wang KS, et al. Use of Corticosteroids After Hepatoportoenterostomy for Bile Drainage in Infants With Biliary Atresia: the START randomized clinical trial. JAMA. 2014 May 7;311(17):1750–10.
Biliary atresia is the most common cause of end-stage liver disease in children. Controversy exists as to whether use of steroids after hepatoportoenterostomy improves clinical outcome.
To determine whether the addition of high-dose corticosteroids after hepatoportoenterostomy is superior to surgery alone in improving biliary drainage and survival with the native liver.
DESIGN, SETTING, AND PATIENTS:
The multicenter, double-blind Steroids in Biliary Atresia Randomized Trial (START) was conducted in 140 infants (mean age, 2.3 months) between September 2005 and February 2011 in the United States; follow-up ended in January 2013.
Participants were randomized to receive intravenous methylprednisolone (4 mg/kg/d for 2 weeks) and oral prednisolone (2 mg/kg/d for 2 weeks) followed by a tapering protocol for 9 weeks (n = 70) or placebo (n = 70) initiated within 72 hours of hepatoportoenterostomy.
MAIN OUTCOMES AND MEASURES:
The primary end point (powered to detect a 25% absolute treatment difference) was the percentage of participants with a serum total bilirubin level of less than 1.5 mg/dL with his/her native liver at 6 months posthepatoportoenterostomy. Secondary outcomes included survival with native liver at 24 months of age and serious adverse events.
The proportion of participants with improved bile drainage was not statistically significantly improved by steroids at 6 months posthepatoportoenterostomy (58.6% [41/70] of steroids group vs 48.6% [34/70] of placebo group; adjusted relative risk, 1.14 [95% CI, 0.83 to 1.57]; P = .43). The adjusted absolute risk difference was 8.7% (95% CI, -10.4% to 27.7%). Transplant-free survival was 58.7% in the steroids group vs 59.4% in the placebo group (adjusted hazard ratio, 1.0 [95% CI, 0.6 to 1.8]; P = .99) at 24 months of age. The percentage of participants with serious adverse events was 81.4% [57/70] of the steroids group and 80.0% [56/70] of the placebo group (P > .99); however, participants receiving steroids had an earlier time of onset of their first serious adverse event by 30 days posthepatoportoenterostomy (37.2% [95% CI, 26.9% to 50.0%] of steroids group vs 19.0% [95% CI, 11.5% to 30.4%] of placebo group; P = .008).
CONCLUSIONS AND RELEVANCE:
Among infants with biliary atresia who have undergone hepatoportoenterostomy, high-dose steroid therapy following surgery did not result in statistically significant treatment differences in bile drainage at 6 months, although a small clinical benefit could not be excluded. Steroid treatment was associated with earlier onset of serious adverse events in children with biliary atresia.
Dr von Allmen’s comments:
· Dr von Allmen would not use corticosteroids after Kasai procedure.
· The difference of bile drainage in the steroid group versus control (58.6% vs 48.6%) was not significant enough to continue use of corticosteroids.
Comparative Effectiveness of Skin Antiseptic Agents in Reducing Surgical Site Infections: A Report from the Washington State Surgical Care and Outcomes Assessment Program
Discussed by Dr George Whit Holcomb
Hakkarainen TW, Dellinger EP, Evans HL, Farjah F, Farrokhi E, Steele SR, et al. Comparative Effectiveness of Skin Antiseptic Agents in Reducing Surgical Site Infections: A Report from the Washington State Surgical Care and Outcomes Assessment Program. J Am Coll Surg. 2014 Mar 1;218(3):336–44.
Surgical site infections (SSI) are an important source of morbidity and mortality. Chlorhexidine in isopropyl alcohol is effective in preventing central venous-catheter associated infections, but its effectiveness in reducing SSI in clean-contaminated procedures is uncertain. Surgical studies to date have had contradictory results. We aimed to further evaluate the relationship of commonly used antiseptic agents and SSI, and to determine if isopropyl alcohol has a unique effect.
We performed a prospective cohort analysis to evaluate the relationship of commonly used skin antiseptic agents and SSI for patients undergoing mostly clean-contaminated surgery from January 2011 through June 2012. Multivariate regression modeling predicted expected rates of SSI. Risk adjusted event rates (RAERs) of SSI were compared across groups using proportionality testing.
Among 7,669 patients, the rate of SSI was 4.6%. The RAERs were 0.85 (p = 0.28) for chlorhexidine (CHG), 1.10 (p = 0.06) for chlorhexidine in isopropyl alcohol (CHG+IPA), 0.98 (p = 0.96) for povidone-iodine (PVI), and 0.93 (p = 0.51) for iodine-povacrylex in isopropyl alcohol (IPC+IPA). The RAERs were 0.91 (p = 0.39) for the non-IPA group and 1.10 (p = 0.07) for the IPA group. Among elective colorectal patients, the RAERs were 0.90 (p = 0.48) for CHG, 1.04 (p = 0.67) for CHG+IPA, 1.04 (p = 0.85) for PVI, and 1.00 (p = 0.99) for IPC+IPA.
For clean-contaminated surgical cases, this large-scale state cohort study did not demonstrate superiority of any commonly used skin antiseptic agent in reducing the risk of SSI, nor did it find any unique effect of isopropyl alcohol. These results do not support the use of more expensive skin preparation agents.
Dr Holcomb’s comments:
· This paper would not change his choice of antiseptic agent. Dr Holcomb feels that iodine based agents and chlorhexidine agents are equally appropriate based on these results.
· Dr Holcomb uses chlorhexidine and isopropyl alcohol for skin preparation.