Preoperative Indocyanine Green Lymphography and High-Frequency Ultrasound as Predictors of Lymphaticovenous Anastomosis Outcome in Post-Mastectomy Upper Limb Lymphedema
研究概览
详细说明
Post-mastectomy upper limb lymphedema is a chronic and progressive condition that significantly affects quality of life and upper limb function. Lymphaticovenous anastomosis (LVA) has emerged as an effective physiologic surgical treatment for selected patients with functioning lymphatic channels. However, predicting surgical success remains challenging.
Indocyanine green (ICG) lymphography and high-frequency ultrasound are increasingly used for preoperative evaluation and surgical planning in lymphedema surgery. These imaging modalities allow visualization of lymphatic vessel patency, lymphatic flow patterns, vessel diameter, and recipient vein characteristics, potentially improving patient selection and operative outcomes.
This prospective interventional study aims to assess the role of preoperative ICG lymphography and high-frequency ultrasound as predictors of successful LVA outcomes in patients with post-mastectomy upper limb lymphedema.
Eligible patients diagnosed with secondary upper limb lymphedema following breast cancer treatment will undergo detailed clinical evaluation, limb measurements, ICG lymphography staging, and ultrasound vessel mapping before surgery. Patients will then undergo supermicrosurgical lymphaticovenous anastomosis.
Primary outcomes will include postoperative reduction in limb circumference and improvement in clinical symptoms. Secondary outcomes will include correlation between imaging findings and surgical success, postoperative complication rates, and patient-reported functional improvement.
The study is expected to contribute to improving patient selection criteria and optimizing preoperative planning for LVA surgery in breast cancer-related lymphedema.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:mohammed hisham abdelhafez, MD
- 电话号码:+201153353229
- 邮箱:mohammedzayan@aun.edu.eg
学习地点
-
-
-
Asyut、埃及、71515
- Assiut University hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
• Female patients aged 18 to 75 years.
- Unilateral secondary upper limb lymphedema following mastectomy with axillary lymph node dissection.
- Minimum interval of six months from completion of oncological treatment (surgery, radiotherapy, systemic therapy) to enrollment.
- ISL clinical stage I or II at the time of enrollment; late stage II eligible if patent lymphatic vessels are identified on preoperative HFUS.
- Provision of written informed consent (prospective phase).
Exclusion Criteria:
Bilateral upper limb lymphedema.
- Active locoregional or distant oncological recurrence.
- Prior lymphatic surgery on the affected limb.
- Severe peripheral vascular disease.
- Pregnancy or planned pregnancy during the study follow-up period.
- Documented hypersensitivity to indocyanine green or iodine
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:lymphatic-venous-anastamosis
Patients with post-mastectomy upper limb lymphedema undergoing preoperative indocyanine green lymphography and high-frequency ultrasound assessment followed by lymphaticovenous anastomosis surgery.
|
Supermicrosurgical lymphaticovenous anastomosis performed for treatment of post-mastectomy upper limb lymphedema following preoperative imaging assessment.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
reduction in upper limb circumference after lymphatic venous anastomosis
大体时间:6 months postoperative
|
Assessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.
|
6 months postoperative
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ASSIUT-LVA-2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.