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胃癌手术后静脉血栓栓塞症的前瞻性多中心观察研究(SHISA-1601)。

A Prospective Multicenter Observational Study of Venous Thromboembolism after Gastric Cancer Surgery (SHISA-1601).

机构信息

Department of Surgery, Shiga University of Medical Science, Otsu, Japan,

Department of Surgery, Shiga University of Medical Science, Otsu, Japan.

出版信息

Eur Surg Res. 2021;62(1):10-17. doi: 10.1159/000514309. Epub 2021 Mar 3.

Abstract

INTRODUCTION

This study aimed to clarify the frequency and risk factors of intercurrent venous thromboembolism (VTE) in patients undergoing major curative gastric cancer surgery.

METHODS

This prospective, multicenter, observational study included patients with gastric cancer who underwent radical gastrectomy at 5 hospitals between June 2016 and May 2018. Patients who were preoperatively administered anticoagulants were excluded.

RESULTS

A total of 126 patients were eligible to participate. VTE occurred within 9 days postoperatively in 5 cases (4.0%; 2 symptomatic and 3 asymptomatic). Postoperative day (POD) 1 plasma D-dimer and soluble fibrin (SF) levels were significantly higher in the VTE group than in the non-VTE group. Receiver-operating characteristic curve (ROC) analysis indicated a statistically significant ability of POD 1 D-dimer and SF levels to predict postoperative VTE development after gastrectomy; this finding was reflected by an area under the curve (AUC) of 0.97 (95% CI 0.92-1.0) and 0.87 (95% CI 0.74-1.0), respectively. Cutoff values of D-dimer (24.6 µg/mL) and SF (64.1 µg/mL) were determined. Intraoperative blood transfusion (odds ratio [OR] 7.86), POD 1 D-dimer ≥24.6 µg/mL (OR 17.35), and POD 1 SF ≥64.1 µg/mL (OR 19.5) were independent predictive factors for postoperative VTE (p < 0.05).

CONCLUSION

VTE occurred in 4.0% patients (1.6% symptomatic and 2.4% asymptomatic) after gastric cancer surgery; however, with an early diagnosis and anticoagulant therapy, no patients experienced progression. Careful observation of patients with a high risk for VTE, including intraoperative blood transfusion and high POD 1 D-dimer or SF levels, would contribute to the early detection of VTE.

摘要

简介

本研究旨在阐明接受根治性胃癌手术的患者中并发静脉血栓栓塞症(VTE)的频率和风险因素。

方法

这是一项前瞻性、多中心、观察性研究,纳入了 2016 年 6 月至 2018 年 5 月在 5 家医院接受根治性胃切除术的胃癌患者。排除了术前接受抗凝治疗的患者。

结果

共有 126 名患者符合入选条件。5 例(4.0%;2 例有症状,3 例无症状)在术后 9 天内发生 VTE。VTE 组术后第 1 天(POD1)血浆 D-二聚体和可溶性纤维蛋白(SF)水平明显高于非 VTE 组。受试者工作特征曲线(ROC)分析表明,POD1D-二聚体和 SF 水平对预测胃癌手术后 VTE 发展具有统计学意义;这一发现反映在曲线下面积(AUC)分别为 0.97(95%CI0.92-1.0)和 0.87(95%CI0.74-1.0)。确定 D-二聚体(24.6µg/mL)和 SF(64.1µg/mL)的截断值。术中输血(比值比[OR]7.86)、POD1D-二聚体≥24.6µg/mL(OR17.35)和 POD1SF≥64.1µg/mL(OR19.5)是术后 VTE 的独立预测因素(p<0.05)。

结论

胃癌手术后,4.0%(1.6%有症状,2.4%无症状)的患者发生 VTE;然而,通过早期诊断和抗凝治疗,没有患者出现病情进展。对 VTE 风险较高的患者进行仔细观察,包括术中输血以及 POD1D-二聚体或 SF 水平升高,有助于早期发现 VTE。

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