Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

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

Detailed Description
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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.

Official Title
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Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial

Conditions
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Incompetent Perforating Veins

Intervention / Treatment
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* Procedure: treatment: puncture of coagulation
* Procedure: treatment: sclerosing agent injected


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group (electrocoagulation)<br>Participants in the experimental group will receive ultrasound-guided puncture of coagulation incompetent perforator veins. | Procedure: treatment: puncture of coagulation<br>* ultrasound-guided puncture of coagulation<br>|
| Active Comparator: control group (sclerotherapy)<br>Participants in the control group will receive an ultrasound-guided sclerosing agent injected. | Procedure: treatment: sclerosing agent injected<br>* ultrasound-guided sclerosing agent injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPVs occlusion rate in the 12th month. | IPVs occlusion rate is defined as DS > 50% for each modality with no procedure no procedure performed on the treated segment | 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life scale survey results | quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score).Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). | 1-month,6-month,12-month | 
| Skin ulcer recurrence rate | Skin ulcer recurrence | 1-month,6-month,12-month | 
| Proportion of participants with deep venous Thrombosis | deep venous Thrombosis | 1-month,6-month,12-month | 
| Proportion of participants with hemorrhage | Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding | 1-month,6-month,12-month | 
| All-cause mortality and other vascular events and serious complications. | Percentage of participants with all deaths | 1-month,6-month,12-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforating veins, Venous disease, Venous ulcer, Sclerotherapy, Electrocoagulationt