Preoperative High-Dose Corticosteroids in Digestive Cancer Surgery: A Randomized Clinical Trial.
- Design
- Design 9 of 10
- Novelty
- Novelty 6 of 10
- Journal
- Journal 10 of 10
- Clinical
- Clinical 9 of 10
Summary
In this double-blind, placebo-controlled multicenter trial across 23 French hospitals, 1,210 patients undergoing elective curative digestive cancer surgery were randomized to intravenous methylprednisolone 20 mg/kg or placebo. Among 1,188 patients with 30-day follow-up, major postoperative complications occurred in 23% versus 20%, respectively, without a statistically significant difference, and no secondary outcome was improved.
Key Findings
- Among 1,188 patients with 30-day follow-up, major postoperative complications occurred in 23% of the methylprednisolone group and 20% of the placebo group, with no significant difference (P = .16).
- Postoperative infections, intra-abdominal infections, unsatisfactory wound healing, and hospital length of stay did not differ significantly between groups.
- The trial concluded that preoperative high-dose corticosteroids provided no postoperative benefit and should not be recommended routinely.
Clinical Implications
Routine administration of a preoperative pulse dose of methylprednisolone 20 mg/kg should not be recommended for elective digestive cancer surgery solely to reduce postoperative complications or inflammation. Clinicians should continue to use corticosteroids only for established indications and weigh procedure-specific risks and benefits.
Why It Matters
This large, rigorous trial directly addresses a controversial perioperative intervention and provides practice-changing negative evidence. Its results argue against routine preoperative high-dose corticosteroids in elective digestive cancer surgery, preventing ineffective treatment and potential steroid-related harm.
Limitations
- The findings apply primarily to elective digestive cancer surgery with curative intent and may not generalize to emergency surgery or isolated hepatic surgery.
- Follow-up for the primary analysis was limited to 30 postoperative days, so long-term oncologic or functional effects were not established.
Future Directions
Future research should determine whether selected subgroups, specific procedures, or different corticosteroid regimens have distinct effects, while incorporating longer-term oncologic, infectious, and patient-reported outcomes. Current work should prioritize implementation studies that reduce unnecessary perioperative steroid use.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Large, multicenter, double-blind, placebo-controlled randomized clinical trial with prospectively registered methodology.
- Study Design