Early Detection of Secondary Lymphedema After Cancer Treatments
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- number of lymphatic vessels visualized
研究概览
简要总结
Many clinical situations in oncologic surgery imply the need to dissect more or less extensively lymph node stations which are in direct relation with the lymphatic drainage of the anatomical region affected by cancer.
The dissected lymph nodes drain generally several regions, and their dissection reduces then the drainage capacity of all these regions, increasing the risk for the patient to develop a secondary lymphedema, shorter or longer after surgery.
Efficient treatments exist, but are difficult to implement and to continue for a long time.The later the treatment of the lymphedema begins, the heavier it is, both on the medical and socio-economic level.
The lymphofluoroscopy, shows that some oncologic patients, operated and free of apparent secondary lymphedema, present abnormalities of the lymphatic network.
The present study aims to confirm that it is now possible to detect secondary lymphedema at a subclinical stage.
详细描述
Many clinical situations in oncologic surgery imply the need to dissect more or less extensively lymph node stations which are in direct relation with the lymphatic drainage of the anatomical region affected by cancer.
The dissected lymph nodes drain generally several regions, and their dissection reduces then the drainage capacity of all these regions, increasing the risk for the patient to develop a secondary lymphedema, shorter or longer after surgery.
The recent meta-analysis show that nearly 15% of patient operated for a cancer with lymph node dissection develop after 27 months from surgery a lymphedema of the limb corresponding to the operated region.
Radio- and chemotherapy may especially encumber the already reduced lymphatic capacity.
The impact on the health and the quality of life of the patient is very significant on the physical and psychological aspect, but also on social and economic aspect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patients who will undergo lymphadenectomy (either large lymphadenectomy or sentinel lymph node biopsy) for oncologic reason (gynaecologic, urologic or mammary cancer, melanoma and other skin cancer) without measurable or observable limb lymphedema.
- •Informed consent form signed.
排除标准
- •Allergy to iodine.
- •Incapaciy to give informed consent.
- •< 18 years.
- •Pregnancy or breastfeeding.
- •Coronary disease.
- •Advanced renal impairment.
- •Hyperthyroidism.
研究组 & 干预措施
lymphofluoroscopy
Indocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
number of lymphatic vessels visualized
时间窗: 12 monthes
次要结局
未报告次要终点