General Surgery Journal Club Presentation

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General Surgery Journal Club Presentation

• Megan Hobson

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Randomized Study of the Benefits of Preoperative
Corticosteroid Administration on the
Postoperative Morbidity and Cytokine Response in
Patients Undergoing Surgery for Oesophageal Cancer

• Nobuhiro S, Keisuke K, Kenichiro I, Yusuke K,
  Kiichi A, Takeshi I, Yuji A, Kaoru I, Kazuyoshi
  S, Shigeatsu E
• Annals of Surgery 236 (2) 184 190
• August 2002

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Objective

• Effect of preoperative corticosteroids on
• postoperative morbidity
• cytokine levels

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Study Design

• Double blinded randomised control trial
• 10mg/kg methylprednisolone vs placebo
• Standardised surgical procedure and post-op
  management
• Sample size calculated based on pilot study
  results (alpha 0.05, 80 power)

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Setting

• Iwate Medical University, Japan ?
  Hospital
• Relatively large number operations 250 between
  1990-1995
• Low complication rates anastomotic leak 1.5,
  intraoperative massive haemorrhage 5,
  postoperative haemorrhage 1
• 1996 - 99

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Subjects

• Oesophageal SCC
• Exclusion criteria
• Preoperative chemo-, radiation or immunotherapy
• gt 76 years
• Preoperative medical condition - cirrhosis, DM,
  obstructive airways disease, renal impairment
• Hep B or C
• Multiple cancers
• Old tuberculous lesions

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• 66 subjects
• 60 males (91), 6 females
• Average age
• 64 in control group, 62 in MP group
• Tumour stage
• I 10.6
• II 37.9
• III 51.5
• No significant difference between control and MP
  groups

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Intervention

• Methylprednisolone 10mg/kg in 100mL normal saline
• Within 30 mins start of surgery
• T1 2.8 hours

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Outcome measures

• Postoperative medical complications (within 7
  days)
• gt 1 organ system failure
• MOF scores abnormal values leading to mortality
  of 10
• Infection - ve culture and clinical evidence

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• Surgical complications (within 30 days)
• Plasma concentrations of IL-6, IL-8, IL-10,
  IL-1ra, cortisol
• Duration of mechanical ventilation
• Long term survival

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Results

• Postoperative complications (from Table 3)

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• Mechanical ventilation
• 3 days (MP group) vs 5 days (control)
• P 0.0009
• No significance difference in
• surgical complications
• Short term mortality
• 1- and 3-year survival

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Laboratory tests

• MP group showed
• Lower postoperative plasma levels of IL-8, IL-6
  and IL-1a
• Higher levels of IL-10
• No change in neutrophil or lymphocyte counts

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Conclusions

• Preoperative administration of methylprednisolone
• Showed beneficial influence on postoperative
  pulmonary and cardiac complications
• Reduced overall morbidity associated with surgery
  for oesophageal cancer

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Limitations

• Size
• Single centre
• No data on subgroups
• Limited analysis of adverse effects
• Clinical outcomes vs laboratory results
• Increased antiinflammatory cytokine IL-10
• ? but reduced IL-1a

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Value

• Study design / validity
• Relative risk reduction 46
• Absolute risk reduction 28
• Number needed to treat 3.57

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• Significant reduction in important endpoints
• Economic considerations
• ? Extrapolation to other patient groups
• Neoadjuvant therapy
• Other operations