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).

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).