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临床试验/NCT06606145
NCT06606145已完成不适用

Influence of the Microsugical Treatment (by Free Node Transfer And/or Lympho-venous Anastomosis (LVA)) of Secondary Lymphedema Following Axillary Lymph Node Dissection or Sentinel Node Biopsy, on the Health Related Quality of Life, Limb Volume Change, Subcutal and Dermal Thickness

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
1
主要终点
Relative interlimb difference

研究概览

简要总结

This clinical trial aims to evaluate the effectiveness of lymphatic microsurgical treatments in reducing limb volume in female patients with breast cancer-related lymphedema (BCRL).

The study focuses on three treatments: Lymphovenous Anastomosis (LVA), Vascularized Lymph Node Transfer (VLNT), and Complex Decongestive Therapy (CDT).

The main questions it aims to answer are:

  • Can LVA, VLNT, or their combination significantly reduce limb volume in patients with BCRL?
  • How does the effectiveness of these surgical interventions compare to CDT alone?

Researchers will compare patients who undergo LVA, VLNT, or a combination of both to those receiving only CDT to determine the effectiveness of surgical interventions in reducing lymphedema symptoms.

Participants will:

  • Undergo pre- and post-operative limb volume measurements.
  • Receive either LVA, VLNT, or combined LVA and VLNT surgery, or continue CDT alone.
  • Be monitored for one year to assess changes in limb volume and quality of life.

详细描述

This clinical trial aims to explore the effectiveness of surgical interventions for breast cancer-related lymphedema (BCRL), a chronic and often debilitating condition caused by lymphatic system damage following breast cancer treatments, such as lymph node dissection or radiation therapy. BCRL affects a significant proportion of breast cancer survivors, leading to arm swelling, discomfort, restricted mobility, and recurrent infections.

Standard management of BCRL includes conservative measures known as Complex Decongestive Therapy (CDT), which involves manual lymphatic drainage, compression therapy, exercise, and skincare. While CDT offers symptomatic relief, it does not address the underlying lymphatic dysfunction. In contrast, microsurgical procedures like Lymphovenous Anastomosis (LVA) and Vascularized Lymph Node Transfer (VLNT) are emerging as more definitive treatments for BCRL, targeting the lymphatic system itself.

LVA involves connecting small functional lymphatic vessels to nearby veins, allowing lymphatic fluid to bypass damaged lymph nodes and enter the venous system, improving drainage. It is particularly suited for patients with early-stage lymphedema (ISL stage I) where functional lymphatic vessels are still present.

VLNT involves transferring healthy lymph nodes along with their blood supply from a donor site (such as the groin or lateral thorax) to the affected area, promoting lymphangiogenesis and improving lymphatic transport. VLNT is more suitable for advanced stages of lymphedema (ISL stage II), where lymphatic vessels are more severely damaged.

The study will evaluate the outcomes of patients who undergo LVA, VLNT, or a combination of both, in comparison to a control group receiving only CDT. The surgical selection is based on preoperative imaging with indocyanine green (ICG) lymphography to assess the status of the lymphatic system. Each patient's lymphedema stage, severity, and individual characteristics are taken into consideration when choosing the most appropriate treatment.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •at least one of the following persistent complaints of one of the upper extremities: heaviness, pain, recurrent infections

排除标准

  • •negative volume difference between affected and normal limb, bilateral mastectomy, bilateral axillary lymph node dissection (ALND), ongoing radio- and chemotherapy, ISL stage III, and receiving other simultaneous debulking procedures during lymphedema surgery.

研究组 & 干预措施

Lymphovenous Anastomoses (LVA)

Experimental

Patients with BCRL recieve one ore more Lymphovenous Anastomoses (LVA) on the affected limb. This involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage. All patients had CDT pre- and post-op.

干预措施: Lymphovenous Anastomosis (Procedure)

Vascularized Lymph Node Transfer (VLNT)

Experimental

Patients with BCRL recieve a Vascularized Lymph Node Transfer (VLNT) on the affected limb. This involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis. All patients had CDT pre- and post-op.

干预措施: Vascularized Lymph Node Transfer (Procedure)

LVA + VLNT

Experimental

Patients with BCRL recieve a combined simultaneous surgical intervention during which both VLNT and one or more LVA are performed on the affected limb. All patients had CDT pre- and post-op.

干预措施: Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer (Procedure)

Complex Decongestive Therapy (CDT)

Active Comparator

Patients with BCRL who refuse to undergo further surgical treatment after breast cancer surgery are offered conservative therapy. The current standard of care for most BRCL patients includes conservative measures known as Complex Decongestive Therapy (CDT) consisting of compression therapy with low-stretch bandages, manual lymphatic drainage, exercise, and skincare.

干预措施: Complex Decongestive Therapy (Procedure)

结局指标

主要结局

Relative interlimb difference

时间窗: Before intervention and one year post-intervention

Change in relative interlimb difference (RID) between the affected and contralateral limb

次要结局

  • Number of infection episodes after surgery(One year post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moustapha Hamdi

Prof. Dr. Moustapha Hamdi

Universitair Ziekenhuis Brussel

研究点 (1)

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