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临床试验/CTRI/2025/11/097651
CTRI/2025/11/097651尚未招募不适用

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

Christian Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:

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

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.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr SURABHI SINGH

CHRISTIAN MEDICAL COLLEGE

研究点 (1)

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