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NOT YET RECRUITING
NCT07445425
NA

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

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2026-03

Completion Date

2026-12

Last Updated

2026-03-03

Healthy Volunteers

Yes

Interventions

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.

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.

Locations (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, 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