比较静脉内激光消融治疗大隐静脉主干同时或分别治疗静脉曲张属支的治疗方案（芬兰主干研究）：一项多中心平行组随机对照研究。
A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study.
机构信息
University of Turku, Turku, Finland.
Department of Vascular Surgery, Turku University Hospital, Turku, Finland.
出版信息
PLoS One. 2023 May 23;18(5):e0285823. doi: 10.1371/journal.pone.0285823. eCollection 2023.
BACKGROUND
Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease.
METHODS
Consecutive patients with symptomatic varicose disease (CEAP clinical class C2-C3) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded.
TRIAL REGISTRATION
Registered on ClinicalTrials.gov, ID NCT04774939.
背景
在静脉曲张疾病中，关于静脉主干消融术与曲张静脉属支治疗相关的观点存在差异。此外，属支在静脉曲张疾病复发中的可能作用尚不清楚。FinnTrunk 研究的目的是在随机分组的情况下比较两种不同的静脉曲张疾病治疗策略。在第一组中，初始治疗将是静脉内激光消融（EVLA）治疗功能不全的大隐静脉主干，而不治疗属支。在第二组中，曲张静脉属支将采用超声引导下泡沫硬化疗法（UGFS）联合主干消融进行治疗。主要结局测量指标是随访期间需要进行额外治疗的情况。次要结局测量指标是治疗成本和静脉曲张疾病的复发情况。
方法
对有症状的静脉曲张疾病（CEAP 临床 C2-C3 级）患者进行研究筛选。符合研究标准并签署知情同意书的患者将被安排手术，并随机分配到研究组。患者将在 3 个月、1 年、3 年和 5 年进行随访。术后 3 个月将根据数字评分量表（NRS）记录术后疼痛评分和镇痛药使用情况，以及可能发生的与手术相关的并发症。1 年后将记录患者报告的结局测量指标（PROMs）。将在每次随访时记录治疗静脉曲张属支的额外治疗、阿伯丁静脉曲张问卷（AVVQ）、静脉临床严重程度评分（VCSS）和健康相关生活质量（EQ-5D-5L）的数据。每次就诊都将进行双功能超声（DUS）检查，并记录静脉曲张属支的数据和额外治疗的需求。
试验注册
ClinicalTrials.gov 注册，编号 NCT04774939。
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