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临床试验/NCT02504684
NCT02504684已完成不适用

Endovenous Laser Ablation of the Great Saphenous Vein Comparing 1920-nm and 1470-nm Diode Laser

Instituto Vascular BH2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
2
主要终点
Venous segment occlusion at one-year follow-up

研究概览

简要总结

Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus 1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients with varicose veins associated with great saphenous reflux were included. Procedures were performed between February and April of 2013. The 1470-nm laser ablation was performed in continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set between 5 and 6 W. Checking for vein closure was performed during the thermal ablation procedure, LEED (linear endovenous energy density) being calculated after the procedure. Follow-up data were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and involved clinical and ultrasound evaluation, measurement of occlusion extent.

详细描述

INTRODUCTION The treatment of varicose veins secondary to saphenous vein reflux has undergone a major shift in the past decade, primarily led by the introduction of less invasive techniques. Wavelengths of 810, 940 and 980 nm have higher rates of absorption by hemoglobin. Water chromophore is associated with an initial energy absorption peak at 980 nm, followed by peaks at 1500 and 2000 nm. The energy released into the vein lumen is therefore absorbed by water as well as by cellular and interstitial proteins. In contrast, laser beams with longer wavelengths act more specifically on water absorbance, resulting in less energy expenditure, such as in the case of the 1470-nm diode endolaser. An endoluminal energy density (LEED) around 50-160 J/cm has been demonstrated to effectively lead to venous occlusion, although LEEDs above 100 J/cm can also be associated with higher complication rates. In contrast, the 1920-nm diode laser is more specific for water and hemoglobin chromophores, tissue absorption at this wavelength being at least 2.5 times greater than the one obtained with the 1470-nm laser. It is therefore expected that less energy would be required to generate the same amount of venous closure.

The aim of this study is to compare diode 1920-nm versus 1470-nm laser in the treatment of great saphenous vein reflux. The primary outcome was venous segment occlusion at the one-year follow-up. Secondary outcomes included LEED, postoperative complications, and clinical outcomes measured through the Clinical, Etiology, Anatomical and Pathological classification (CEAP), the Venous Clinical Severity Score (VCSS) and a patient satisfaction scale.

METHODS This is a prospective study to evaluate the results of the 1920-nm vs. 1470-nm laser. Patients agreeing to participate were offered informed consent, recruitment occurring between February and April of 2013. Participants enrolled between February and mid-March of 2013 underwent treatment with the 1470-nm laser, while those enrolled between mid-March and April underwent treatment with the 1920-nm laser.

Patients between 18 and 70 years old who had varicose veins associated with reflux of the great saphenous veins were included. The exclusion criteria were: patients with a previous history of thrombophlebitis, deep vein thrombosis or who had undergone any previous surgery for this condition, thermal ablation or sclerotherapy. For bilateral cases, both limbs were treated during the same surgical session.

Data on clinical history, physical examination, CEAP classification, VCSS (Venous Clinical Severity Score) and VDS (Venous Disability Score) were collected. The extent of the great saphenous reflux was measured along with its main diameter at the level of the saphenofemoral junction as well as at the knee level. Reflux was defined as retrograde when reaching a speed greater than 3 cm/second during a Valsalva maneuver or through leg compression maneuvers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with varicose veins associated with reflux of great or small saphenous veins

排除标准

  • Patients under 18 years old or over 70 years.
  • Acute or previous thrombophlebitis or deep vein thrombosis.
  • Pregnant patient.

结局指标

主要结局

Venous segment occlusion at one-year follow-up

时间窗: one year

Extent of venous occlusion measured in centimeters. The length of occluded vein segment is measured and compared with total extension of the vein treated with the endolaser.

次要结局

  • Ecchymosis extension(7 days)
  • Presence of induration(30 days)
  • Presence of Paresthesia(30 days)
  • Skin burns(7 days)
  • Deep vein thrombosis(7 days)

研究者

发起方
Instituto Vascular BH
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Mendes Pinto

Daniel Mendes Pinto, MD

Instituto Vascular BH

研究点 (2)

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