Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура treatment: puncture of coagulation
  ultrasound-guided puncture of coagulation
• Процедура treatment: sclerosing agent injected
  ultrasound-guided sclerosing agent injected

Первичные конечные точки

• IPVs occlusion rate in the 12th month. [Срок оценки: 12 months after operation]

Вторичные конечные точки (5)

• Quality of life scale survey results [Срок оценки: 1-month,6-month,12-month]
• Skin ulcer recurrence rate [Срок оценки: 1-month,6-month,12-month]
• Proportion of participants with deep venous Thrombosis [Срок оценки: 1-month,6-month,12-month]
• Proportion of participants with hemorrhage [Срок оценки: 1-month,6-month,12-month]
• All-cause mortality and other vascular events and serious complications. [Срок оценки: 1-month,6-month,12-month]

Критерии участия

Критерии включения

(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.

Критерии исключения

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Anhui Provincial Hospital — Хэфэй
• Yantai Yuhuangding Hospital — Yantai
• Zhongshan Hospital affiliated to Fudan University — Шанхай
• Sir Run Run Shaw Hospital — Ханчжоу
• The second affiliated hospital of zhejiang university school of medicine — Ханчжоу

Публикации

• Cooper DG, Hillman-Cooper CS, Barker SG, Hollingsworth SJ. Primary varicose veins: the sapheno-femoral junction, distribution of varicosities and patterns of incompetence. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):53-9. doi: 10.1053/ejvs.2002.1782. PMID 12525812
• Sakurai T, Matsushita M, Nishikimi N, Nimura Y. Hemodynamic assessment of femoropopliteal venous reflux in patients with primary varicose veins. J Vasc Surg. 1997 Aug;26(2):260-4. doi: 10.1016/s0741-5214(97)70187-3. PMID 9279313
• Guex JJ. Ultrasound guided sclerotherapy (USGS) for perforating veins (PV). Hawaii Med J. 2000 Jun;59(6):261-2. No abstract available. PMID 10916243
• 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. PMID 16520171
• 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 PMID 21536172
• 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. PMID 26946896

Идентификаторы

NCT: NCT04686097 · SAHZhejiangU-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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