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
1 other identifier
interventional
206
1 country
21
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 3, 2026
November 1, 2025
9 months
November 17, 2025
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The re-intervention rate
1 week, 3 months and 6 months after surgery
Secondary Outcomes (12)
Treatment cost
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
- +7 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Dezhou People's Hospital
Dezhou, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zibo First Hospital
Zibo, Shandong, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
March 3, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 3, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share