Incompetent Perforating Veins
Conditions
Keywords
Perforating veins, Venous disease, Venous ulcer, Sclerotherapy, Electrocoagulationt
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.
Interventions
PROCEDUREtreatment: puncture of coagulation
ultrasound-guided puncture of coagulation
PROCEDUREtreatment: sclerosing agent injected
ultrasound-guided sclerosing agent injected
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Shanghai Zhongshan Hospital
Yantai Yuhuangding Hospital
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPVs occlusion rate in the 12th month. | 12 months after operation | IPVs occlusion rate is defined as DS \> 50% for each modality with no procedure no procedure performed on the treated segment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life scale survey results | 1-month,6-month,12-month | 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). |
| Skin ulcer recurrence rate | 1-month,6-month,12-month | Skin ulcer recurrence |
| Proportion of participants with deep venous Thrombosis | 1-month,6-month,12-month | deep venous Thrombosis |
| Proportion of participants with hemorrhage | 1-month,6-month,12-month | Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding |
| All-cause mortality and other vascular events and serious complications. | 1-month,6-month,12-month | Percentage of participants with all deaths |
Countries
China
Contacts
CONTACTZhen jie Liu
PRINCIPAL_INVESTIGATORZhen jie Liu, MD,PhD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed