Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
Condition: Lymphedema of Upper Arm
MeSH terms: Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      Breast cancer is the most common cancer in women. It is an important health problem that has
      been increasingly encountered in recent years. With advances in treatment, the survival time
      after breast cancer is prolonged, and as a result, many women face certain diseases during
      this period. One of these diseases, breast cancer-related lymphedema, is characterized by
      abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at
      any time after breast cancer surgery or radiotherapy and is a major cause of morbidity.Early
      and accurate diagnosis of lymphedema is very important for effective treatment. In routine
      clinical practice there are various methods used to diagnose lymphedema such as history,
      physical examination and limb circumference. Circumferential measurement is based on the
      principle of circumference measurement at certain intervals (such as 4 cm, 5 cm, 10 cm) from
      certain anatomical reference points on the extremities. Volume calculation can also be made
      from a data obtained from circumferential measurements via a computer program.
      Circumferential and volume measurements are used in the diagnosis, severity of lymphedema and
      follow-up of treatment. Although it is the most commonly used method in practice,
      circumferential measurements and volume measurements alone can ignore changes in tissue
      structure and significant changes in the presence of latent lymphedema. At the same time,
      circumferential measurements are made at regular intervals and the difference between the
      healthy side and 2 cm or more is considered as lymphedema, which may neglect tissue and edema
      changes in areas not in the measuring area. Ultrasonography, which has been used in the
      measurement and evaluation of lymphedema in recent years, is a noninvasive economic method.
      Skin and subcutaneous distance in lymphedema can be measured by ultrasonography, and changes
      in tissue structure, fibrous tissue, adipose tissue and muscle tissue can be demonstrated.
      Fibrotic changes in lymphedema tissue play a key role in progression. Subcutaneous ultrasound
      echogenicity (SEG), which is thought to be a measure of lymphedema severity in extremities,
      was determined as stages 0, 1 and 2. According to this; Stage 0: No increase in echogenicity
      in the subcutaneous layer. That is, the subcutaneous fat layer is observed as black. Stage 1:
      Diffuse increase in echogenicity, but identifiable horizontal or oblique-focused echogenic
      lines caused by bundles of connective tissue may be seen. In this study, the investigators
      aimed to determine the correlation between circumferential measurements and skin and
      subcutaneous tissue ultrasonography in breast cancer-related lymphedema patients.The primer
      aim of this study is to investigate the correlation between circumferential measurements and
      ultrasonographic measurements in breast cancer-related lymphedema. The secondary aim is to
      investigate the relationship among the changes in subcutaneous tissue structure (subcutaneous
      ultrasound echogenicity degree-SEG) and lymphedema severity in breast cancer-related
      lymphedema.
    

Detailed description: 
      Patients with unilateral breast cancer-related lymphedema will be included in the study. The
      circumferences will be measured with a measuring tape from wrist ulnar styloid to axilla at 4
      cm intervals. The point where the difference between the upper extremities was highest and
      the control point with no difference in the lower extremities will be marked.
      Ultrasonographic skin and subcutaneous thickness measurements will be performed from 4
      quadrants; volar medial-lateral and dorsal medial-lateral sides of the extremity, with the
      probe placed transverse and perpendicular to the skin at the marked points.

      The severity of lymphedema was graded ultrasonographically according to the SEG scale. (Stage
      0: No increase in echogenicity in the subcutaneous layer. That is, subcutaneous fat is
      observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or
      oblique-oriented echogenic lines caused by bundles of connective tissue can be seen. Stage 2:
      A widespread increase in echogenicity echogenic lines cannot be identified.) Spearman test
      was used for correlations and Receiver Operating Characteristics (ROC) curve analysis was
      used to estimate the diagnostic accuracy. Sensitivity and specificity were calculated using a
      statistically significant threshold. Differences between ultrasonographic measurements
      between control points in lower extremities were compared with Wilcoxon test.

      The minimum number of patients to be included in the study, according to the G-Power program,
      effect size d = 0.5, alpha-α = 0.05 and power 0.80 was calculated to be at least 34.
    

Intervention name(s): ultrasonographic measurement
Intervention type(s): Diagnostic Test
Intervention description(s): ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lymphedema; Circumferential measurements; ultrasonography