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临床试验/NL-OMON55376
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

发起方
Medisch Universitair Ziekenhuis Maastricht

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