NL-OMON55376招募中3 期
Improving the quality of life of patients with breast cancer-related lymphedema by lymphaticovenous anastomosis (LVA): A randomized controlled trial - LYMPH-trial
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Women over 18 years old
- •- Treated for early stage breast cancer and who underwent a sentinel lymph node
- •biopsy, axillary lymph node dissection or axillary radiotherapy
- •- Early stage lymphedema of the arm (ISL classification stage I/IIa; pitting
- •edema without fibrosis) with viable lymphatic vessels as determined by
- •indocyanin green (ICG-) lymphography
- •- Already received at least three months of complex decongestive therapy
- •(currently in the maintenance phase) prior to inclusion
- •- Primary breast cancer
- •- Unilateral lymphedema
- •- Informed consent
排除标准
- •- Male sex
- •- Late stage lymphedema of the arm (ISL classification IIb/III lymphedema) with
- •evident fat deposition and/or fibrosis
- •- History of earlier lymph reconstruction efforts
- •- Recurrent breast cancer
- •- Distant breast cancer metastases
- •- Bilateral lymphedema
- •- Primary congenital lymphedema
- •- Non-viable lymphatic system as determined by ICG lymphography
研究者
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