Preoperative High-Dose Corticosteroids in Digestive Cancer Surgery: A Randomized Clinical Trial.

Abstract

Importance Modulating perioperative inflammation could be associated with fewer postoperative complications and better outcomes in major digestive surgery. The clinical benefit of corticosteroids with this purpose remains controversial. Objective To assess whether preoperative high-dose corticosteroids improve postoperative outcomes after surgery for digestive cancer. Design, Setting, and Participants This double-blind, placebo-controlled, superiority randomized clinical trial included patients undergoing elective surgery with curative intent for digestive cancer. This was a multicenter trial with the participation of 23 French hospitals working as a reference for digestive surgical oncology. Among patients referred for major digestive surgery to the participating centers, those undergoing surgery for digestive cancer with a curative intent between 2019 and 2023 were randomized. Patients undergoing only hepatic surgery without digestive anastomosis were excluded. Interventions Patients included were randomized to receive either 20 mg/kg of intravenous methylprednisolone at the time of anesthesia or a placebo with an identical aspect. Main Outcomes and Measures The primary end point was the onset of major postoperative complications within 30 days after surgery. Secondary end points were postoperative infections, intra-abdominal infections, wound infections, unsatisfactory wound healing within 30 days after surgery, and the length of hospital stay after surgery. Results Among 2461 patients referred for major digestive surgery, 1210 patients (mean [SD] age, 65.9 [11.3] years; 762 male [63%]) undergoing surgery for digestive cancer were randomized. Among the 1188 patients with follow-up at postoperative day 30 (594 per arm), major postoperative complications did not significantly differ between the 2 groups (139 of 594 [23%] receiving methylprednisolone vs 119 of 594 [20%] receiving placebo; P = .16). Secondary outcomes did not differ either between the group receiving methylprednisolone and the group receiving placebo (postoperative infections: 182 of 594 [31%] vs 177 of 594 [30%]; P = .75; intra-abdominal infections: 142 of 594 [24%] vs 126 of 594 [21%]; P = .27; unsatisfactory wound healing: 87 of 594 [15%] vs 69 of 594 [12%]; P = .13; mean [SD] length of hospital stay: 13.21 [8.59] days vs 12.97 [8.1] days; P = .93). Conclusions and Relevance 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. Trial Registration ClinicalTrials.gov Identifier: NCT03875690.