Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of vessels planned for surgery surgery
研究概览
简要总结
The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.
详细描述
BACKGROUND
Breast-cancer related lymphedema is a life-disabling side-effect of breast cancer treatment, affecting more than 1 in every 5 patients. With breast-cancer being the most common cancer diagnosis in women, affecting up to 2.3 million new cases globally, and with a generally high survival rate of 80% or higher in developed countries, the number of breast-cancer survivors with long-term sequela is significant. Compression garments have been considered the standard treatment and rehabilitation for lymphedema. Some of the disadvantages with these treatments include variability in patient compliance, clinical effect and lack of statistical significant results. Therefore, the rehabilitation and treatment options for lymphedema are in high demand, affecting patients physical and mental health.
Lymphovenous anastomosis (LVA) surgery is an attempt to re-establish the lymphatic flow, utilizing the patient's own lymphatic- and venous vessels. Surgical treatment seems effective in selective patient groups, but systematic studies for this are lacking. It is based on this lack of knowledge of patient characteristics and preoperative planning that the project's hypothesis and idea was formed.
Indocyanine green (ICG) lymphography is commonly used for identification of lymphatic vessels pre-operatively, and is considered superior to other modalities. However, until recently, the identification of adjacent venoles has remained a challenge. Ultra high frequency ultrasound may have solved the challenge of identifying the small venoles prior to surgery. The combined use of ICG lymphography and ultra high frequency ultrasound may be the key to optimise patient selection and pre-operative planning of lymphovenous anastomosis surgery.
METHOD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Iatrogenic lymphedema following treatment for breast cancer in upper extremity
- •Possible to obtain informed consent
排除标准
- •Duration of disease over 24 months
- •Untreated or uncontrolled primary cancer
- •No applicable lymphatic vessels identified, using ICG lymphangiography
- •No applicable venous vessels identified using ultra high frequency ultrasound
研究组 & 干预措施
Lymphovenous anastomosis surgery
Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.
干预措施: Lymphovenous anastomosis (Procedure)
结局指标
主要结局
Number of vessels planned for surgery surgery
时间窗: Preoperative
The number of mapped lymphatics vessels and venoles.
Number of vessels found during surgery
时间窗: Perioprative
The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.
次要结局
- Changes of fat mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
- Changes in L-Dex score(Baseline and 3 months follow-up)
- Changes of arm volume(Baseline and 3 months follow-up)
- Change of extracellular fluid (liters) relative to total body water (liters), measured in percentage.(Baseline and 3 months follow-up)
- Changes of intracellular fluid (liters) relative to total body water (liters), measured in percentage.(Baseline and 3 months follow-up)
- Changes of total body water (liters) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
- Changes of proteins and minerals (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
- Changes in health-related quality-of-life measured by the LYMPH-Q questionnaire(Baseline and 3 months follow-up)
- Changes in active tissue mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
- Changes of skeletal muscle mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
- Changes of lymphatic flow pattern before and after surgery by ICG lymphangiography(Baseline and 3 months follow-up)
研究者
Caroline Lilja
Principal Investigator
Odense University Hospital
