Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins

Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study

The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:

Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?

Participants will:

Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.

Record their symptoms

Study Overview

• Status: Not yet recruiting
• Conditions: Varicose Veins of Lower Limb
• Intervention / Treatment: Procedure: Staged surgery group; Procedure: Concomitant surgery group

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meijia Xu; Phone Number: +8619700777750; Email: 1341506760@qq.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical University
      • Contact: Zhaowen Yu; Phone Number: 8613309651876
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University Third Hospital
      • Contact: Changming Wang
    • Beijing, Beijing Municipality, China
      • Peking University International Hospital
      • Contact: Qian Wang
  • Guangxi
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi University of Chinese Medicine
      • Contact: Yaochang Luo; Phone Number: 8615907713918
    • Nanning, Guangxi, China
      • Guangxi Zhuang Autonomous Region People's Hospital
      • Contact: Lei Yu; Phone Number: 8613387719938
  • Hainan
    • Haikou, Hainan, China
      • Hainan Provincial Hospital of Traditional Chinese Medicine
      • Contact: Chuang Wang; Phone Number: 8613514808066
  • Henan
    • Zhengzhou, Henan, China
      • Zhengzhou Central Hospital
      • Contact: Bin Song
    • Zhoukou, Henan, China
      • Zhoukou Central Hospital
      • Contact: Xianwei Qi
  • Hunan
    • Chenzhou, Hunan, China
      • The First People's Hospital of Chenzhou
      • Contact: Yide Zheng
  • Jiangsu
    • Huai'an, Jiangsu, China
      • Huai'an First People's Hospital
      • Contact: Gang Xu; Phone Number: 8618851258521
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital of Traditional Chinese Medicine
      • Contact: Weihua Jiang; Phone Number: 8613770662060
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Weimin Zhou; Phone Number: 8613870658585
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
      • Contact: Ming Qi; Phone Number: 8618098875991
    • Shenyang, Liaoning, China
      • The First Affiliated Hospital of China Medical University
      • Contact: Jian Zhang
  • Shandong
    • Dezhou, Shandong, China
      • Dezhou People's Hospital
      • Contact: Haiqing Wang; Phone Number: 8613053420366
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
      • Contact: Lubin Li; Phone Number: 8618653587355
    • Zibo, Shandong, China
      • Zibo First Hospital
      • Contact: Tong Liu; Phone Number: 8613156987626
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Zhenjie Liu
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Contact: Meijia Xu, Postgraduate; Phone Number: +8619700777750; Email: 1341506760@qq.com
      • Contact: Yuefeng Zhu
      • Principal Investigator: Yuefeng Zhu, Archiater
      • Sub-Investigator: Huanhuan Chen, Attending physician
      • Sub-Investigator: Qiang Zheng, Certified doctor
    • Hangzhou, Zhejiang, China
      • Hangzhou Third People's Hospital
      • Contact: Luyang Meng; Phone Number: 13777831991
    • Shaoxing, Zhejiang, China
      • Affiliated Hospital of Shaoxing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.

Exclusion Criteria:

Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Procedure: Staged surgery group; The patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequency catheter and advanced the tip to approximately 2 cm at the junction of the saphenofemoral vein, where it will be left in place. Under ultrasound guidance, the needle will be tightly attached to the GSV sheath, and an anesthetic solution will be injected to treat the swelling until the junction of the saphenofemoral vein will be reached. Then, we will secure the tip of the radiofrequency catheter and switch on the radiofrequency generator and ablated the primary trunk of the GSV in segments.
Placebo Comparator: B	Procedure: Concomitant surgery group; While the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The re-intervention rate	1 week, 3 months and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment cost	According to the statistics of hospital charging system	6 months after surgery
Success rate of varicose vein closure		1 week, 3 months and 6 months after surgery
Operation time		During the operation
Number of incisions		During the operation
Tumescent anesthesia solution dosage		During the operation
The amount of intraoperative bleeding		During the operation
AVVQ score	The Aberdeen varicose vein questionnaire. The score range is 0-100, and the higher the score, the worse the result.	Before surgery, 1 week, 3 months and 6 months after surgery
VAS score	Visual analogue scale. The score range is 0-10, and the higher the score, the worse the result.	Before surgery, 1 week, 3 months and 6 months after surgery
VCSS score	Venous clinical severity score. The score range is 0-30, and the higher the score, the worse the result.	Before surgery, 1 week, 3 months and 6 months after surgery
Postoperative complications		1 week, 3 months and 6 months after surgery
Time to return to regular work		1 week after surgery
Patient satisfaction	Include two question: "The quality of treatment that you received was good?" "The treatment that you received fulfilled your expectations?"	During the operation and 6 months after surgery

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-2700-01

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: No