Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- B Mode Ultrasonography Measurements
研究概览
简要总结
The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.
详细描述
Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For the patient group
- •between the ages of 18-75
- •diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
- •being stage 0-1-2 lymphedema according to ISL staging For the control group
- •between the ages of 18-75
- •no history of breast cancer
排除标准
- •History of surgery in the assessment area
- •History of trauma at the assessment site
- •Active infection in the assessment area
- •Presence of congenital or acquired malformations at the assessment site
- •Primary lymphedema
- •those with any medical condition that may cause edema, such as advanced heart or kidney failure
结局指标
主要结局
B Mode Ultrasonography Measurements
时间窗: Day 0
Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG
Shear Wave Elastography Measurements
时间窗: Day 0
Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography
次要结局
- Association of USG and SWE Measurements With Functionality(Day 0)
- Association of USG and SWE Measurements With Symptoms(Day 0)
- Association of USG and SWE Measurements With Participation İn Daily Life(Day 0)
- Association of USG and SWE Measurements With Volume Measurements(Day 0)