Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Trials. 2024 Sep 6;25(1):591. doi: 10.1186/s13063-024-08408-y.
The purpose of the study is to examine if prolonged thromboprophylaxis decreases the risk of thrombosis after intended curative surgery for oesophageal cancer. Study results are expected to inform a guideline for thromboprophylaxis after oesophageal cancer surgery. The perspective is to reduce morbidity and mortality in this critically ill patient group. Thrombosis is the second-most common cause of cancer death after the cancer itself. The risk of thrombosis depends on the cancer type, and upper gastrointestinal cancers are considered high risk. This risk is further increased when patients undergo surgery. However, only few studies have investigated the peri- and postoperative coagulation profile in oesophageal cancer patients. Due to this lack of knowledge, prophylaxis is currently restricted to 5000 IU (international units) low-molecular weight heparin daily from surgery until discharge from hospital (approximately 10 days), whereas patients with gastric cancer receive 30 days of treatment. The present study examines whether a 30-day treatment is superior and safe, compared with the current standard treatment.
The study is a randomised controlled trial. Inclusion is ongoing, and we aim to include 100 patients. Blood samples are drawn before and after surgery, and the coagulation is extensively examined. The primary endpoint is the difference in plasma levels of prothrombin fragment 1 + 2 (F1 + 2) 30 days after surgery between the intervention and the standard group. Furthermore, patients are examined with ultrasound to screen for asymptomatic venous thrombotic events (VTE). Secondary endpoints are incidence of bleeding, symptomatic and asymptomatic VTE and mortality 30 days 1 one year after surgery.
The study will provide valuable information on the perioperative coagulation profile and VTE risk of oesophageal cancer patients. The study seeks to aid in optimising the postoperative thromboprophylaxis, and the perspective is to reduce morbidity and mortality in this at-risk patient population.
The trial was prospectively registered at the EU Clinical Trials Register with ID 2021-001335-24 on 30 June 2021 and at ClinicalTrials.gov with study identifier NCT05067153.
本研究旨在探讨延长血栓预防治疗是否能降低接受根治性手术治疗的食管癌患者血栓形成的风险。研究结果将为食管癌手术后血栓预防治疗指南提供信息。研究旨在减少这一重症患者群体的发病率和死亡率。血栓形成是癌症相关死亡的第二大常见原因，仅次于癌症本身。血栓形成的风险取决于癌症类型，上消化道癌症被认为是高危类型。当患者接受手术时，这种风险会进一步增加。然而，只有少数研究调查了食管癌患者围手术期的凝血谱。由于缺乏这方面的知识，目前的预防措施仅限于从手术到出院（大约 10 天）每天使用 5000 国际单位（IU）低分子肝素，而接受胃癌手术的患者则接受 30 天的治疗。本研究旨在探讨与当前标准治疗相比，30 天的治疗是否更优越和安全。
本研究为一项随机对照试验。目前正在入组患者，我们计划纳入 100 例患者。在手术前后采集血样，并对凝血进行广泛检查。主要终点是干预组和标准组手术后 30 天血浆中凝血酶原片段 1+2（F1+2）水平的差异。此外，还通过超声检查筛查无症状静脉血栓栓塞事件（VTE）。次要终点是术后 30 天、1 年时的出血、有症状和无症状 VTE 以及死亡率。
本研究将提供有关食管癌患者围手术期凝血谱和 VTE 风险的有价值信息。本研究旨在帮助优化术后血栓预防治疗，并旨在降低这一高危患者群体的发病率和死亡率。
该试验于 2021 年 6 月 30 日在欧盟临床试验注册中心以 ID 2021-001335-24 前瞻性注册，并在 ClinicalTrials.gov 以研究标识符 NCT05067153 注册。
