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Clinical Trial
. 2002 Aug;236(2):184-90.
doi: 10.1097/00000658-200208000-00006.

Randomized study of the benefits of preoperative corticosteroid administration on the postoperative morbidity and cytokine response in patients undergoing surgery for esophageal cancer

Nobuhiro Sato  1 , Keisuke Koeda, Kenichiro Ikeda, Yusuke Kimura, Kiichi Aoki, Takeshi Iwaya, Yuji Akiyama, Kaoru Ishida, Kazuyoshi Saito, Shigeatsu Endo
Affiliations
Clinical Trial

Randomized study of the benefits of preoperative corticosteroid administration on the postoperative morbidity and cytokine response in patients undergoing surgery for esophageal cancer

Nobuhiro Sato et al. Ann Surg. 2002 Aug.

Abstract

Objective: To investigate whether preoperative corticosteroid administration plays a role in attenuating postoperative morbidity.

Summary background data: There is as yet no consensus on the beneficial effects of steroids in alleviating surgical stress.

Methods: A total of 66 patients undergoing surgery for thoracic esophageal cancer were randomly categorized preoperatively into two groups of 33 patients each. One group was administered an intravenous infusion of methylprednisolone (10 mg/kg body weight) 30 minutes before the surgery (MP group), while the other group received a placebo infusion (control group). The primary endpoint was organ system failure during the first 7 days after surgery. Comparisons of surgery-related complications, cytokine responses, and blood counts were also made between the two groups.

Results: The percentage of patients in the MP group who had one or more organ system failures was 33%, significantly lower than the corresponding percentage of 61% in the control group. The surgery-related complication rate and long-term survival rate were similar in the two groups. The peak plasma levels of interleukin (IL)-1 receptor antagonist, IL-6, and IL-8 were significantly lower in the MP group than in the control group. Changes in the plasma levels of IL-10 were significantly larger in the MP group. No significant differences in the circulating lymphocyte and neutrophil counts were observed between the groups.

Conclusions: The results suggest that prophylactic administration of corticosteroids is associated with a decrease in postoperative morbidity in patients undergoing invasive surgery. The laboratory data suggest that corticosteroids may attenuate surgical stress-induced inflammatory responses both directly by suppressing the release of proinflammatory cytokines and via inducing IL-10 synthesis.

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Figures

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Figure 1. Kaplan-Meier curves for the duration of mechanical ventilation in the methylprednisolone group (solid line) and the control group (dashed line). The median duration (with 95% confidence interval [CI]) of mechanical ventilation was 3 days (95% CI 2.4–3.6) in the methylprednisolone group as compared with 5 days (95% CI 4.1–5.9) in the control group (P = .0009, log-rank test).
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Figure 2. Kaplan-Meier curves for long-term survival in the methylprednisolone group (solid line) and the control group (dashed line). No statistically significant differences in the overall survival rates were found between the two groups (P = .4465, log-rank test). The 1- and 3-year survival rates were 82% and 62% in the methylprednisolone group and 85% and 65% in the control group, respectively.
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Figure 3. Postoperative changes in the plasma levels of interleukin (IL)-8 (top), IL-6 (middle), and IL-1ra (bottom) in the methylprednisolone group (○ and the control group (▪). The postoperative increases in the plasma levels of IL-8, IL-6, and IL-1ra were significantly suppressed in the methylprednisolone group (P < .01, analysis of variance, respectively). **P < .01, *P < .05, methylprednisolone group versus control group (paired t test).
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Figure 4. Postoperative changes in the plasma levels of cortisol (left) and interleukin (IL)-10 (right) in the methylprednisolone group (○ and the control group (▪). Since methylprednisolone shows 43% cross-reactivity with cortisol, the levels of cortisol during the operation were higher in the methylprednisolone group than in the control group (P < .01, analysis of variance), but after that point there were no differences in the cortisol levels between the two groups. The plasma levels of IL-10 were higher in the methylprednisolone group than in the control group (P < .01, analysis of variance). **P < .01, methylprednisolone group versus control group (paired t test).
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Figure 5. Postoperative changes in the circulating lymphocyte counts (left) and neutrophil counts (right) in the methylprednisolone group (○ and the control group (▪). There were no marked differences in lymphocyte and neutrophil counts between the two groups.
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Comment in

  • The role of steroids in surgical practice.
    Coffey C, Naylor DF Jr, Hassan MA. Coffey C, et al. Curr Surg. 2003 May-Jun;60(3):235-40. doi: 10.1016/s0149-7944(03)00025-4. Curr Surg. 2003. PMID: 15212056 No abstract available.

References

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    1. Sato N, Murakami K, Ishida K, et al. Pulmonary hypertension and polymorphonuclear leukocyte elastase after esophageal cancer operation. Ann Thorac Surg 1991; 51: 754–758. - PubMed
    1. Sato N, Koeda K, Kimura K, et al. Cytokine profile of serum and bronchoalveolar lavage fluids following thoracic esophageal cancer surgery. Eur Surg Res 2001; 33: 279–284. - PubMed
    1. Steven M. Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: A phase III, randomized, double-blind, placebo-controlled, multicenter trial. Crit Care Med 1997; 27: 1115–1123. - PubMed
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