Endovenous RFA Versus Ligation and Striping for Varicose Veins

Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial

Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.

Study Overview

• Status: Unknown
• Conditions: Varicose Veins of Lower Limb
• Intervention / Treatment: Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518053
      • University of Hong Kong shenzhen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of long saphenous varicose veins

Exclusion Criteria:

• Contraindicated to operation due to severe comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High ligation and stripping; High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins	Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic); Thermal injury to long saphenous vein; Other Names: ClosureFast, Medtronic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Occlusion of the long saphenous vein	up to 24 months
Complications	Deep vein thrombosis, skin burn	2 weeks after operation
Recurrence of varicose vein	Recurrence of varicose vein	up to 24 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong-Shenzhen Hospital
• Investigators: Principal Investigator: Hailei Li, M.D, Ph.D, University of Hong Kong shenzhen hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; High ligation and striping
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: HKUSZH201901013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes