Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.
Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Trials. 2020 Jun 3;21(1):460. doi: 10.1186/s13063-020-04393-0.
Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins.
METHODS/DESIGN: This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period.
This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins.
Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.
有多种方法可用于治疗静脉曲张。结扎和剥离大隐静脉的开放式手术治疗多年来一直是标准治疗方法。静脉内热消融已被证明是一种安全有效的替代方法，具有较高的长期目标静脉闭塞率。尽管如此，仍有可能对周围结构造成热损伤。最近推出的氰基丙烯酸酯闭合也被认为是一种很好的选择，对周围结构损伤的风险很小。本研究旨在证明与手术剥离相比，使用 VenaSeal™闭合系统进行氰基丙烯酸酯闭合在治疗功能不全大隐静脉方面的临床结果无差异。
方法/设计：这是一项开放标签、多中心、前瞻性、随机对照试验，评估氰基丙烯酸酯闭合与手术剥离治疗功能不全隐静脉的临床结果的非劣效性。在基线测量后，参与者将被随机分配到氰基丙烯酸酯闭合组或手术剥离组。该研究的主要终点是氰基丙烯酸酯闭合组目标静脉的完全闭塞率，以及手术剥离组静脉反流或残留静脉组织的缺失。这些终点将通过由合格的血管技术人员或研究者在治疗后 3 个月进行的多普勒超声测量。次要结局包括围手术期疼痛、术后瘀斑、临床评估（包括一般和疾病特异性生活质量评估）、12 个月和 24 个月随访时的完全闭塞率、静脉反流或残留静脉组织的缺失以及 24 个月随访期间的所有不良事件发生率。
这项多中心随机对照试验旨在证明氰基丙烯酸酯的完全闭塞率与手术剥离治疗功能不全隐静脉相比不劣效。
临床研究信息服务（CRIS），ID：KCT0003203。于 2018 年 9 月 20 日注册。
