Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endovenous ablation for incompetent great saphenous veins
10.16139/j.1007-9610.2025.04.03
- VernacularTitle:氰基丙烯酸正丁酯与射频消融腔内闭合治疗大隐静脉功能不全的随机对照多中心临床研究
- Author:
Jinsong JIANG
;
Hao WU
;
Xinye WANG
;
Dang XIE
;
Changming WANG
;
Xin FANG
;
Chunshui HE
;
Zhenjie LIU
- Publication Type:Journal Article
- From:
Journal of Surgery Concepts & Practice
2025;30(4):302-309
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the 12-month efficacy and safety of N-butyl cyanoacrylate (NBCA) versus radiofrequency ablation (RFA) in treating great saphenous vein (GSV) insufficiency. Methods A total of 155 patients with GSV insufficiency from five centers were randomly allocated to the NBCA group or RFA group. Postoperative efficacy and safety outcomes were evaluated. Results Immediate postoperative closure rates of the GSV trunk were 100% in both groups. The closure rates of NBCA and RFA group were 98.6% and 98.5% at 3 months, 97.1% and 98.5% at 6 months, 98.1% and 95.9% at 12 months, with no statistically significant differences (P>0.05). After treatment, CEAP classification improved significantly from baseline in both groups. In terms of safety, 1 case of phlebitis, 1 case of ablation-related thrombus extension (ARTE) and 2 cases of calf muscle venous thrombosis(CMVT) occurred in the NBCA group, while 2 cases of limb numbness, 1 case of persistent thigh pain and 2 cases of CMVT in the RFA group. All reported serious adverse events in both groups were assessed as unrelated to the medical device or the trial procedure. Conclusions NBCA demonstrates non-inferior efficacy and safety compared to RFA for treating GSV insufficiency over 12 months.
