Clinical trial NCT04686097: Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins
Official title: Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incompetent Perforating Veins
Keywords: Perforating veins
Venous disease
Venous ulcer
Sclerotherapy
Electrocoagulationt
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Shanghai Zhongshan Hospital
name: Yantai Yuhuangding Hospital
name: Anhui Provincial Hospital
First posted: 2020-12-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: IPVs occlusion rate in the 12th month.
timeFrame: 12 months after operation
Secondary outcomes:
measure: Quality of life scale survey results
timeFrame: 1-month,6-month,12-month
measure: Skin ulcer recurrence rate
timeFrame: 1-month,6-month,12-month
measure: Proportion of participants with deep venous Thrombosis
timeFrame: 1-month,6-month,12-month
measure: Proportion of participants with hemorrhage
timeFrame: 1-month,6-month,12-month
measure: All-cause mortality and other vascular events and serious complications.
timeFrame: 1-month,6-month,12-month
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhen jie Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Guex JJ. Ultrasound guided sclerotherapy (USGS) for perforating veins (PV). Hawaii Med J. 2000 Jun;59(6):261-2. No abstract available.
citation: Masuda EM, Kessler DM, Lurie F, Puggioni A, Kistner RL, Eklof B. The effect of ultrasound-guided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores. J Vasc Surg. 2006 Mar;43(3):551-6; discussion 556-7. doi: 10.1016/j.jvs.2005.11.038.
citation: Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
citation: 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.