Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

Varicose Veins Clinical Trial

Official title:

Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372146
• Other study ID #: 192
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: February 27, 2022

Study information

• Verified date: November 2019
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

86 patients were randomized into hot-CHIVA (n=43) and control (n=43) groups. Study group patients had undergone radiofrequency ablation (RFA) VNUS Closure - FastTM of one segment of GSV close to saphenofemoral junction. Controls had undergone whole refluxing trunk ablation. Additional phlebectomy was performed in all the patients of both groups. Primary end-point was change in quality of life (QoL) measured with CIVIQ-20 at 12 months. Secondary end-points was recurrence of varicose veins at 12 months. The investigators also measured GSV caliber at the median and distal thigh change in hot-CHIVA group.

Description:

Aim - to compare GSV segmental radiofrequency ablation (hot-CHIVA) and conventional GSV ablation in varicose veins patients.

This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins. In a study group (hot-CHIVA) GSV segmental ablation with concomitant phlebectomy was performed. Conventional GSV radiofrequency ablation was performed in a control group. Patients were enrolled from November, 2019 to February, 2021.

All patients were examined clinically. Age, height, weight, body mass index, gender, side of disease, personal history of varicose veins were recorded. Medical history was taken. Disease description was made using advanced CEAP classification. Quality of life was measured by CIVIQ-20 and leg discomfort related to CVD symptoms on the operated leg was measured with a 10-cm visual analogue scale (VAS). Duplex ultrasound was performed in a standing position to access deep veins and GSV. We recorded reflux extention and presence of the re-entry perforators on the thigh or upper calf. Diameter of GSV near SFJ, at the middle, and lower part of the thigh was measured at inclusion in the both groups.

Sample size The sample size was calculated considering the average values for the CIVIQ-20 quality of life questionnaire on 2nd year after the endovascular treatment and CHIVA treatment obtained by reviewing the literature. Selected parameters: first-order error (α) 5%; power 80%; boundaries of "non-inferiority limit" 2; the expected difference between the study groups of 0. Taking into account the possible dropout of patients from the study, the size of the groups is increased by 5%. The estimated sample size is 86 participants.

Statistical analysis Data are presented using descriptive statistics. Normally distributed data are presented as mean with standard deviation. Not normally distributed data are presented as (Me) and interquartile range (Q1 - Q3). Two independent groups were compared with Student's t-test or Mann-Whitney test depending on data distribution. Friedman test was used to compare dependent variables. Pearson's chi-squared test or Fisher's exact test were used to compare nominal variables. A p-value of <0.05 was considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 27, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• C2EpAsPrGSVa, C2,3EpAsPrGSVa

• Reflux not lower than upper part of the calf,

• Age more than 18 years,

• SFJ diameter less than 15mm,

• Incompetence of terminal-femoral valve,

• GSV reflux more than 0,5 sec,

• re-entry perforator on the thigh or upper part of the calf for patients in the hot-CHIVA group

Exclusion Criteria:

• C4-C6 class of CEAP

• Pregnancy

• Deep vein reflux more than 1 sec

• SSV reflux more than 0,5 sec

• Interventions for VVs prior to the inclusion

• Those unwilling to sign an informed consent were also included.

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Procedure:
• GSV radiofrequency ablation with concomitant phlebectomy
Radiofrequency ablation with concomitant phlebectomy

Locations

Country	Name	City	State
Russian Federation	Veronika Golovina	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)	There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100.	12 months
Secondary	Varicose veins recurrence	Visual recurrence of varicose veins	12 months
Secondary	Leg discomfort related to CVD symptoms measured with 10-cm visual analogue scale (VAS) at 3 months	Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.; The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).	2nd day, 7th day, 1 months, 3 months
Secondary	In a study group remained GSV trunk diameter at mid- and lower thigh was measured at 1, 3, 6, 12 months after procedure	Diameter of GSV measured by ultrasound	1 months, 3 months, 6 months, 12 months