Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

NCT ID: NCT04686097

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-12-30

Brief Summary

This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.

Detailed Description

Background: Incompetent perforating vein (IPV) is one of the important causes of persistent venous ulcers of lower extremities and recurrence after operation of varices which is a hot button issue worth discussing in clinical practice. Minimally invasive surgery has become the trend of IPVs' treatment. Currently, sclerotherapy can be performed to treat incompetent perforating veins, which showed a 90% occlusion rate after three or fewer sessions, the recurrence was present nearly 1/3 of cases. While electrocoagulation has a reliable effect on the closure of incompetent perforating veins and simplify treatment. No comparative studies of different PAPS modalities are currently available. Therefore, this study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforating veins. Methods:This study is a multicenter, randomized controlled trial. We will recruit 84 patients with IPVs from five hospitals. Moreover, these patients will be randomized to either the experimental group (electrocoagulation) or the control group (sclerotherapy). The primary outcome is incompetent perforating veins occlusion rate in the 12th month. Secondary outcomes are quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score), skin ulcer recurrence rate, deep venous Thrombosis, hemorrhage, all-cause mortality, and other vascular events and serious complications.Discussion:This study will provide reliable, evidence-based clinical evidence for the efficacy of electrocoagulation therapy for incompetent perforating veins.

Conditions

Incompetent Perforating Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group (electrocoagulation)

Participants in the experimental group will receive ultrasound-guided puncture of coagulation incompetent perforator veins.

Group Type: EXPERIMENTAL

treatment: puncture of coagulation

Intervention Type: PROCEDURE

ultrasound-guided puncture of coagulation

control group (sclerotherapy)

Participants in the control group will receive an ultrasound-guided sclerosing agent injected.

Group Type: ACTIVE_COMPARATOR

treatment: sclerosing agent injected

Intervention Type: PROCEDURE

ultrasound-guided sclerosing agent injected

Interventions

treatment: puncture of coagulation

ultrasound-guided puncture of coagulation

Intervention Type: PROCEDURE

treatment: sclerosing agent injected

ultrasound-guided sclerosing agent injected

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

(1) outward flow of less than 500 ms duration, with a diameter of >3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b~C6 grades are included.

Exclusion Criteria

(1)age < 18 years or age > 80 years; (2)with malignant tumors and life expectancy < 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Zhenjie Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen jie Liu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: SUSPENDED

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status: SUSPENDED

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status: SUSPENDED

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status: SUSPENDED

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen jie Liu

Role: CONTACT

lawson4001@zju.edu.cn

86-0571-87913706

Facility Contacts

Zhenjie Liu

Role: primary

lawson4001@zju.edu.cn

15268135830 ext. 86

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Hager ES, Washington C, Steinmetz A, Wu T, Singh M, Dillavou E. Factors that influence perforator vein closure rates using radiofrequency ablation, laser ablation, or foam sclerotherapy. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):51-6. doi: 10.1016/j.jvsv.2015.08.004.

Reference Type: BACKGROUND

PMID: 26946896 (View on PubMed)

Other Identifiers

SAHZhejiangU-003

Identifier Type: -

Identifier Source: org_study_id