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Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data
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.
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.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
Yes
Canan Şanal-Toprak
Istanbul, Turkey (Türkiye)
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
Start Date
February 1, 2022
Primary Completion Date
April 1, 2022
Completion Date
November 1, 2022
Last Updated
August 24, 2023
72
ACTUAL participants
Shear Wave Elastography and B Mode Ultrasonography
DIAGNOSTIC_TEST
Quick Dash Questionnare
DIAGNOSTIC_TEST
The Lymphedema Life Impact Scale
DIAGNOSTIC_TEST
Questioning lymphedema-related symptoms
DIAGNOSTIC_TEST
Extremity circumference and volume measurement
OTHER
Lead Sponsor
Marmara University
NCT06532955
NCT05203835
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06407791