{
  "abstract": "Introduction Both varicose veins (VV) and iliac vein compression syndrome (IVCS) can cause skin damage and functional impairment in the lower extremities, and these issues often coexist. However, the question of whether IVCS exacerbates VV progression and leads to differences in the surgical outcomes of therapy for VV remains unanswered. Therefore, no high-level evidence-based medical data is available to support the concomitant use of iliac vein stenting in patients with VV and severe IVCS, and treatment protocols vary significantly among different centres. This study will investigate the effects of concomitant iliac vein stenting on post-procedure varices recurrence and quality of life (QoL) on the basis of a prospective, multicentre, randomised controlled trial with the goal of providing a foundation for the standardised treatment of patients with VV and IVCS.Methods and analysis This prospective, multicentre, randomised controlled trial will enrol 160 patients with VV and severe IVCS. All patients will be randomly divided into either the VV endovenous thermal ablation (ETA) alone group or the VV ETA combined with iliac vein stenting (ETAS) group. Baseline data will be collected and follow-up will be conducted at 1, 6, 12 and 36 months after the procedure. The primary outcome is post-procedure VV recurrence (as assessed by clinical and ultrasound examination). Secondary outcomes include QoL scores (according to the Aberdeen Varicose Vein Questionnaire, the Chronic Lower Limb Venous Insufficiency Questionnaire, the European Quality of Life Five-Dimensions, and the Venous Clinical Severity Score) and the incidence of post-procedure complications. Bleeding complications resulting from anticoagulation therapy and stent-related complications (such as restenosis and deep vein thrombosis) will also be recorded for patients in the ETAS group.Ethics and dissemination This study has been approved by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (approval number: XJTU1AF2024LSYY-075). Written informed consent has been obtained from all participants. The final results of this study will be published in a peer-reviewed journal and presented at national or international conferences.Trial registration number This protocol was registered on chictr.org.cn prior to enrolment, which began on 19 June 2024 (Registration ID: ChiCTR2400085815).",
  "authors": [
    {
      "affiliations": [
        "Department of Vascular Surgery, the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China, Xi'an, Shaanxi, People's Republic of China"
      ],
      "name": "Longlong Cong"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China"
      ],
      "name": "Fanggang Cai"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, the First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu, People's Republic of China"
      ],
      "name": "Yaowen Chang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, People's Republic of China"
      ],
      "name": "Zhaohui Hua"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People's Republic of China"
      ],
      "name": "Zhipeng Hu"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, The First People’s Hospital of Baiyin, Baiyin, Gansu, People's Republic of China"
      ],
      "name": "Huaxin Hao"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, People's Republic of China"
      ],
      "name": "Jiancang Ma"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, the Xi’an Ninth Hospital, Xi’an, Shaanxi, People's Republic of China"
      ],
      "name": "Lei Ma"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Chengdu First People’s Hospital, Chengdu, Sichuan, People's Republic of China"
      ],
      "name": "Liang Wang"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, the Dongguan People’s Hospital, Donguan, Guangdong, People's Republic of China"
      ],
      "name": "Liang Wang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Fujian Provincial People’s Hospital, Fuzhou, Fujian, People's Republic of China"
      ],
      "name": "Yin Xia"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, Xi’an Honghui Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, People's Republic of China"
      ],
      "name": "Huijun Yuan"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Baoji Central Hospital, Baoji, Shaanxi, People's Republic of China"
      ],
      "name": "Weifeng Yu"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, 215 Hospital of Shaanxi Nuclear Industry, Xianyang, Shaanxi, People's Republic of China"
      ],
      "name": "Feng Zhang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Xiamen Cardiovascular Hospital of Xiamen University, Xiamen, Shaanxi, People's Republic of China"
      ],
      "name": "Hui Zhuang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Shaanxi Provincial People’s Hospital, Xi’an, Shaanxi, People's Republic of China"
      ],
      "name": "Ruipeng Zhang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Second Affiliated Hospital of Air Army Medical University, Xi’an, Shaanxi, People's Republic of China"
      ],
      "name": "Zhang Zhang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the Bethune Hospital of Shanxi Medical University, Taiyuan, Shanxi, People's Republic of China"
      ],
      "name": "Tao Yang"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China, Xi'an, Shaanxi, People's Republic of China"
      ],
      "name": "Lin Yang"
    }
  ],
  "title": "Effects on recurrence and quAlity-of-life of iliac vein Stenting angioplasTy for patients with Varicose veins combined with severE Iliac veiN compression: a protocol for a prospective, multicentre, randomised clinical trial (EAST-VEIN trial)",
  "uid": "81864070-8d70-51f0-b107-dced14c5238d"
}