Ntalouka Maria P, Symeonidis Dimitrios, Kotsi Paraskevi, Petinaki Efthymia, Matsagkas Miltiadis, Tepetes Konstantinos, Zacharoulis Dimitrios, Arnaoutoglou Eleni M
Department of Anaesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa University Hospital, Thessaly, Greece.
Department of Surgery, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa University Hospital, Thessaly, Greece.
BMC Surg. 2025 Apr 26;25(1):183. doi: 10.1186/s12893-024-02665-z.
Pancreatic cancer is probably the most thrombotic malignancy, with an incidence of venous thromboembolism (VTE) of up to 18%. However, the exact pathophysiological mechanisms involved in the development of VTE in the setting of pancreatic cancer are not yet well understood. The primary endpoint of the study is to evaluate the neutrophil/lymphocyte ratio (NLR) and other coagulation biomarkers as predictors of VTE in patients with pancreatic cancer undergoing surgery with curative intent. The exact incidence of VTE, perioperative coagulation status of patients and the possible determinants of VTE in the aforementioned population are the secondary study objectives.
This prospective, non-interventional observational study is conducted according to the STROBE concept. It has been approved by the ethical committee and registered (NCT05964621) and will include eligible patients with primary pancreatic cancer with resectable or borderline resectable disease undergoing surgery with curative intent. Exclusion criteria are: Refusal to participate, previous thromboembolic event < 6 months, ASA score > 3, patients deemed inoperable intraoperatively and the concurrent presence of a second primary malignancy. Three blood samples are taken from all patients (preoperatively, immediately after the operation, and before discharge) and the serum values of the following parameters are determined: Haemoglobin, white blood cells, INR, liver and kidney function tests, von Willebrand factor, factors VIII and XI, D-dimers, fibrinogen, platelet function, Adamts 13 and anti-Xa. One month after the procedure, scheduled screening for asymptomatic deep vein thrombosis (DVT) is performed with a lower extremity ultrasound triplex study. In addition, thromboembolic events (DVT, pulmonary embolism (PE)) diagnosed during the hospital stay period are recorded. Low molecular weight heparin will be routinely administered from the first postoperative day, with the dosage, i.e. prophylactic or therapeutic titrated according to the patient's history of cardiovascular disease. According to the literature, the pooled specificity of the admission NLR for 30-day VTE and PE prediction is 80.5%, while the VTE rates after pancreatectomy is 1.5%. Based on a 95% confidence level and a precision of 0.1, the estimated sample size for the specificity outcome is 62 patients.
The aim of this study is to identify predictors of postoperative VTE in patients undergoing pancreatic cancer surgery. The results could lead to an optimization of perioperative care.
NCT05964621. Registered on July, 2023 clinicaltrials.org.
胰腺癌可能是最易引发血栓形成的恶性肿瘤，静脉血栓栓塞（VTE）的发生率高达18%。然而，胰腺癌患者发生VTE的确切病理生理机制尚未完全明确。本研究的主要终点是评估中性粒细胞/淋巴细胞比值（NLR）和其他凝血生物标志物，作为接受根治性手术的胰腺癌患者发生VTE的预测指标。VTE的确切发生率、患者围手术期的凝血状态以及上述人群中VTE的可能决定因素是次要研究目标。
本前瞻性、非干预性观察性研究按照STROBE概念进行。已获得伦理委员会批准并注册（NCT05964621），将纳入符合条件的原发性胰腺癌患者，这些患者患有可切除或临界可切除疾病，并接受根治性手术。排除标准为：拒绝参与、既往血栓栓塞事件发生时间<6个月、美国麻醉医师协会（ASA）评分>3、术中被判定无法手术以及同时存在第二种原发性恶性肿瘤。从所有患者身上采集三份血样（术前、术后即刻和出院前），并测定以下参数的血清值：血红蛋白、白细胞、国际标准化比值（INR）、肝肾功能检查、血管性血友病因子、凝血因子VIII和XI、D-二聚体、纤维蛋白原、血小板功能、含血小板解聚蛋白和金属蛋白酶13（Adamts 13）以及抗Xa因子。术后1个月，采用下肢超声三联检查对无症状深静脉血栓形成（DVT）进行定期筛查。此外，记录住院期间诊断出的血栓栓塞事件（DVT、肺栓塞（PE））。术后第一天将常规给予低分子量肝素，剂量根据患者心血管疾病史进行预防性或治疗性滴定。根据文献，入院时NLR对30天VTE和PE预测的合并特异性为80.5%，而胰十二指肠切除术后的VTE发生率为1.5%。基于95%的置信水平和0.1的精度，特异性结果的估计样本量为62例患者。
本研究的目的是确定接受胰腺癌手术患者术后VTE的预测指标。研究结果可能会优化围手术期护理。
NCT05964621。于2023年7月在clinicaltrials.org注册。
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