The Effect of Perioperative Dexamethasone on Postoperative Complications After Pancreaticoduodenectomy

医学 胰十二指肠切除术 胰瘘 地塞米松 围手术期 安慰剂 随机对照试验 麻醉 入射(几何) 外科 内科学 胰腺 光学 物理 病理 切除术 替代医学
作者
Haoda Chen,Ying Wang,Kuirong Jiang,Zhiwei Xu,Yu Jiang,Zhichong Wu,Xiaojian Lu,Chao Wang,Yuanchi Weng,Weishen Wang,Rui Ding,Shifan Zheng,Yilong Li,Xu Fu,Guodong Shi,Jiancheng Wang,Hao Chen,Chenghong Peng,Xiaxing Deng,Yudong Qiu
出处
期刊:Annals of Surgery [Lippincott Williams & Wilkins]
卷期号:280 (2): 222-228 被引量:14
标识
DOI:10.1097/sla.0000000000006240
摘要

Objective: To evaluate the effect of perioperative dexamethasone on postoperative complications after pancreaticoduodenectomy. Background: The glucocorticoid dexamethasone has been shown to improve postoperative outcomes in surgical patients, but its effects on postoperative complications after pancreaticoduodenectomy are unclear. Methods: This multicenter, double-blind, randomized controlled trial was conducted in four Chinese high-volume pancreatic centers. Adults undergoing elective pancreaticoduodenectomy were randomized to receive either 0.2 mg/kg dexamethasone or a saline placebo as an intravenous bolus within 5 minutes after anesthesia induction. The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days after the operation, analyzed using the modified intention-to-treat principle. Results: Among 428 patients for eligibility, 300 participants were randomized and 265 were included in the modified intention-to-treat analyses. One hundred thirty-four patients received dexamethasone and 131 patients received a placebo. The mean (SD) CCI score was 14.0 (17.5) in the dexamethasone group and 17.9 (20.3) in the placebo group (mean difference: −3.8; 95% CI: −8.4 to 0.7; P = 0.100). The incidence of major complications (Clavien-Dindo grade ≥III; 12.7% vs 16.0%, risk ratio: 0.79; 95% CI: 0.44 to 1.43; P = 0.439) and postoperative pancreatic fistula (25.4% vs 31.3%, risk ratio: 0.81; 95% CI: 0.55 to 1.19; P = 0.286) were not significantly different between the two groups. In the stratum of participants with a main pancreatic duct ≤3 mm (n = 202), the CCI score was significantly lower in the dexamethasone group (mean difference: −6.4; 95% CI: −11.2 to −1.6; P = 0.009). Conclusions: Perioperative dexamethasone did not significantly reduce postoperative complications within 30 days after pancreaticoduodenectomy.
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