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临床试验/NCT07449728
NCT07449728招募中不适用

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

Pirogov Russian National Research Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Number of patients with reflux recurrence at the sapheno-femoral junction

研究概览

简要总结

Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Similar technical efficacy is expected for laser crossectomy at 1940 nm and 1470 nm. A possible advantage of the 1940 nm wavelength in terms of postoperative pain intensity and the risk of adverse events cannot be ruled out.

详细描述

Chronic venous disorder (CVD), including primary varicose veins (VV) of the lower limbs and progressive forms with chronic venous insufficiency (CVI), is an important medical and social problem due to its high prevalence in the population and its significant burden on healthcare systems. According to general data, up to 19% of the population has primary varicose veins, and up to 13.5% has signs of CVI. At present, the main approach to surgical treatment of VVs is the elimination of pathological reflux, for which minimally invasive endovascular techniques are recommended. The latter, including endovascular laser treatment (EVLT), is noninferior to open surgery in technical efficiency but is associated with a lower risk of postoperative complications. Among all adverse events after EVLT, the most important one is venous thromboembolism (VTE), including endovenous heat-induced thrombosis (EHIT). The incidence of EHIT may depend on the position of the laser fiber relative to the sapheno-femoral junction (SFJ).

Recurrent varicose veins, occurring in 10-62% of patients, are the leading consequence of varicose vein surgery in long-term follow-up. The causes of recurrence depend on the type of primary intervention, with recanalization and reflux recurrence at the SFJ after EVLT being the most common.

In order to reduce the risk of varicose veins recurrence, it was proposed to perform a "laser crossectomy" (flush or zero ablation), which suggests laser fiber position just near the wall of the femoral vein without a traditional 1-2 cm distance from the junction. It is aimed at eliminating the ostia of all adjacent tributaries, including the anterior accessory saphenous vein (AASV), as in a traditional open surgery. To date, the limited evidence of laser crossectomy demonstrates its relative safety and technical feasibility in 57-100%, as well as a contradictory effect on the recurrence rate, including reflux on AASV.

At the same time, the vast majority of studies on laser crossectomy have been conducted at 1.5 μm (1470-1550 nm). The further development of technology has led to devices producing a wavelength of about 2 μm, which exhibit more selective absorption by water in blood and venous walls, allowing a similar depth of wall injury with lower power. First studies on its use show a high occlusion rate of up to 99%, low postoperative pain levels, and a reduced frequency of EHIT (predominantly class 1). Since EHIT of class 1 (superficial vein occlusion up to the level of the deep vein wall) aligns with the intention to perform a laser crossectomy, the use of 2 μm wavelength compared to 1,5 μm can be associated with both improved safety in terms of reducing EHIT of classes 2-4, and lower efficiency due to preservation of a stump with tributaries. Moreover, the technically successful laser crossectomy, despite the reduced risk of reflux recurrence at the SFJ, cannot guarantee the absence of reflux recurrence through other mechanisms. Thus, the question of choosing an optimal wavelength for performing a laser crossectomy, as well as its influence on further progression of GSV reflux, remains open.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Primary VVs of Clinical Etiology Anatomy Pathophysiology (CEAP) clinical class of C2-C6
  • Reflux along the GSV trunk lasting >0.5 sec.
  • GSV trunk diameter ≤12 mm
  • Informed consent to participate in the study

排除标准

  • Primary reflux outside the GSV trunk (including combined reflux)
  • History of deep or superficial vein thrombosis
  • Deep vein reflux
  • Non-thrombotic or post-thrombotic venous obstruction
  • Pelvic venous insufficiency
  • Use of oral anticoagulants
  • Indication for pharmacological prophylaxis after EVLT
  • Inability to use radial fiber of 1.4-1.57 mm at the surgeon's discretion
  • Refusal to participate in the study

研究组 & 干预措施

Group 1 (1470 nm)

Experimental

Laser crossectomy will be performed with a wavelength of 1470 nm and radial fiber with a core diameter of 0.4 mm and a bulb diameter of 1.57 mm at a power of 6-8 W by manual extraction at a speed of 1 mm/s (LED of 60-80 J/cm). EVLT of the great saphenous vein (GSV) trunk will be performed with a standard approach.

干预措施: Laser crossectomy on 1470 nm (Procedure)

Group 2 (1940 nm)

Experimental

Laser crossectomy will be performed with a wavelength of 1940 nm and radial fiber with a core diameter of 0.55 mm and a bulb diameter of 1.4 mm at a power of 4-6 W by manual extraction at a speed of 1 mm/s (LED of 40-60 J/cm). EVLT of the GSV trunk will be performed with a standard approach.

干预措施: Laser crossectomy on 1940 nm (Procedure)

Control

Active Comparator

Will contain patients who have failed to perform laser crossectomy at 1470 nm or 1940 nm wavelength due to technical impossibility or technical failure, and underwent EVLT of the GSV trunk with preservation of the stump.

干预措施: Standard EVLT with a stump (Procedure)

结局指标

主要结局

Number of patients with reflux recurrence at the sapheno-femoral junction

时间窗: 12 months

Defined as the presence of reflux, with a duration of \>0.5 sec under provocation manoeuvre (Valsalva manoeuvre and/or manual distal compression), at the zone of treated SFJ, including reflux on recanalized GSV trunk, on the AASV or any other tributaries, on the lymph node venous network, on the inguinal or perineal veins as detected by duplex ultrasound scan (DUS).

次要结局

  • Number of patients with GSV recanalization(12 months)
  • Number of patients with technically possible laser crossectomy(0 days)
  • Number of patients with technically successful laser crossectomy(3 days)
  • Length of GSV stump(12 months)
  • Number of patients with EHIT of 2-4 classes(12 months)
  • Number of patients with clinical recurrence of varicose veins(12 months)
  • Number of patients with ultrasound recurrence of varicose veins(12 months)
  • The value of VCSS score(12 months)
  • The value of CIVIQ-20 score(12 months)

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirill Lobastov

Professor of the Department of General surgery named after V.M. Buyanov

Pirogov Russian National Research Medical University

研究点 (1)

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