TOPLINE

Preoperative methylprednisolone does not reduce major postoperative complications in patients undergoing elective digestive cancer surgery, a new randomized control study found. Among about 1200 patients, major complications occurred in just under a quarter of both the methylprednisolone and the placebo groups, with no significant differences in secondary outcomes.

METHODOLOGY

• Surgery induces a physiologic inflammatory response that, in patients with cancer, adds to the effects of the disease itself, and potential postoperative complications can further increase this inflammatory response. Intense perioperative inflammation has been shown to negatively influence postoperative morbidity and can impair immune response to surgical site infections with negative impact on cancer-related outcomes. Although perioperative corticosteroids effectively decrease inflammatory markers, the specific effect of perioperative corticosteroids in cancer surgery has not been adequately assessed.
• Researchers conducted the multicenter, double-blind trial across 23 French hospitals specializing in digestive surgical oncology between 2019 and 2023. A total of 1210 patients (mean age, 65.9 years; 63% men) undergoing elective surgery with curative intent for digestive cancer were randomized to receive either 20 mg/kg of intravenous methylprednisolone or placebo at anesthesia induction.
• Patients undergoing only hepatic surgery without digestive anastomosis were excluded from the trial, as were those with American Society of Anesthesiologists score > 3 or on long-term oral corticosteroid therapy. 
• The primary outcome was the onset of major postoperative complications (Clavien-Dindo grade > 2) within 30 days after surgery, assessed in 1188 patients (594 per arm) with complete follow-up. Secondary outcomes included postoperative infections, intra-abdominal infections, wound infections, unsatisfactory wound healing within 30 days, and length of hospital stay after surgery. 

TAKEAWAY

• Major postoperative complications within 30 days did not significantly differ between groups: 139 of 594 patients (23%) receiving methylprednisolone vs 119 of 594 (20%) receiving placebo (odds ratio [OR], 1.22; P = .16). 
• No significant differences were observed in postoperative infections (182 of 594 [31%] vs 177 of 594 [30%]; OR, 1.04) or intra-abdominal infections (142 of 594 [24%] vs 126 of 594 [21%]; OR, 1.17). 
• Postoperative C-reactive protein (CRP) levels were significantly lower in the corticosteroid group on postoperative day 1 (mean, 5.81 mg/dL vs 6.76 mg/dL; P < .001) and day 3 (mean, 8.85 mg/dL vs 14.89 mg/dL; P < .001). 
• Patients in the corticosteroid group experienced more episodes of moderate hyperglycemia (160.4-250.5 mg/dL) in the 48 hours after surgery: 137 patients (23%) vs 108 patients (18%; P = .03). 

IN PRACTICE

“A preoperative pulse dose of corticosteroids had no benefit on postoperative outcomes in elective digestive cancer surgery and should not be recommended in routine practice,” the authors of the study wrote.

SOURCE

The study was led by Pablo Ortega-Deballon, MD, PhD, Université Bourgogne Europe, CHU Dijon Bourgogne, Service de Chirurgie Digestive in Dijon, France. It was published online on August 19 in JAMA Surgery.

LIMITATIONS

One limitation was the possibility of unblinding due to steroid effects such as hyperglycemia or hypokalemia, particularly in patients without diabetes, though the influence on robust endpoints like severe morbidity, infections, or length of stay was considered very low. Unblinding could have influenced the perception of wound healing quality at postoperative day 30, though the evaluating surgeon was unlikely to have managed the patient’s postoperative metabolic disorders due to the organization of perioperative care in France. The study excluded patients undergoing hepatic resection alone, which may have introduced bias since hepatectomy complications are less frequently infectious than in digestive tract surgery and corticosteroids show specific benefits related to vascular clamping tolerance in hepatic surgery.

DISCLOSURES

This study received support from grant 12156 provided by the Institut National du Cancer-Direction Générale de l’Offre de Soins (INCa-DGOS). Guillaume Piessen, MD, PhD, disclosed receiving personal fees from BMS, MSD, AstraZeneca, Stryker, and Elivie outside the submitted work. Stéphane Benoist, MD, PhD, disclosed receiving speaker and board service fees from Merck Serono, Roche, Amgen, Takeda, AbbVie, Sanofi, Servier, Win’up Surgical, Fabre, and Kephren outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.