Use of Indocyanine green (ICG) lymphography in early detection of lymphedema and response assessment of compression therapy following axillary dissection in breast cancer patients, a prospective interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Early detection of early(subclinical) lymphedema after breast cancer surgery using ICG lymphography
研究概览
简要总结
Upper limb lymphedema is a common complication following breast cancer treatment. Patient’s quality of life is severely affected. Subclinical lymphedema identification is great help for early treatment and may decrease the chance that the disease will progress to a chronic late stage. Lymphedema can be effectively treated with early identification, resulting in higher success rates and potential cost savings. Incidence of lymphedema varies from 5.6% to 63.4%.
The symptoms of early lymphedema may indicate a sub-clinical lymphatic system disorder without a significant increase in arm circumference. This initial dysfunction can be detected through complementary tests such as indirect lymphography or indocyanine green (ICG) lymphography.
Indocyanine Green (ICG) lymphography is now commonly used to visualize the lymphatic system. Initially, it was used for breast sentinel node biopsy. Its application extends to lymphoedema diagnosis and mapping lymphatic vessels prior to lymphovenous anastomosis (LVA) surgery. ICG lymphography is a newer technique , has higher specificity and sensitivity than lymphoscintigraphy. It has the advantage of having quick pathological visualization of superficial lymph flow in real time, without any radiation exposure. It can reliably and accurately diagnose, track, and stage the severity of lymphedema, ranging from sub clinical or early lymphedema to more advanced cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients undergoing surgery for carcinoma breast including axillary dissection or level one sampling or dissection.
排除标准
- •Age less than 18 years, having secondary edema due to another cause (not breast cancer related), iodine allergy, patient undergoing SLNB or recurrence following previous breast cancer surgery.
结局指标
主要结局
Early detection of early(subclinical) lymphedema after breast cancer surgery using ICG lymphography
时间窗: 3 to 6 months
次要结局
- Identify patients having high risk of developing Lymphedema by the use of ICG lymphography pattern following breast cancer surgery.(Institute early compression physiotherapy or intervention by lymphovenous anastomosis for treatment of lymphedema)
研究者
Dr SURABHI SINGH
CHRISTIAN MEDICAL COLLEGE
