Vascular surgey Lymphovenous center
Leuven, Vlaams Brabant, 3000, Belgium
NCT Number: NCT03210311
Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (>= 3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.
Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet.
This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Leuven, Vlaams Brabant, 3000, Belgium
Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Estimates of incidence rates have varied over time, especially since the progression to less invasive techniques as sentinel node procedures and radiotherapy. According to a review article of DiSipio the incidence of arm lymphedema was about four times higher in women who had an axillary lymph node dissection (18 studies; 19.9%, 13.5-28.2) than in those who had sentinel lymph node biopsy (18 studies; 5.6%, 6.1-7.9). Several other risk factors are already suggested as having a negative impact on the development of lymphedema such as BMI and chemotherapy. A comprehensive overview of all treatment related risk factors and patient related risk factors, including demographics, has not been reported yet.
Lymphedema is identified with upper limb volume measurements eg circumference measurements, water displacement and perometer. Bioimpedance spectroscopy can also be used to assess the extracellular fluid. A 10% limb volume change has been reported as the most accurate threshold to diagnose lymphedema. However, with this definition an underestimation of the incidence rate of lymphoedema is made. Therefore, recently a threshold of 5% limb volume change is proposed.
A study by Rockson et al suggested that in almost 75 % of the cases, lymphoedema is established in the first year after breast cancer treatment. But up to two years after surgery, there still is a possibility to develop lymphoedema.
Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (>= 3% volume change) that recognizes subclinical lymphedema is promoted.
When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.
During near-infrared fluorescence lymphography (lymphofluoroscopy), a fluorescent substance is injected subcutaneously in the hand and the transport of lymph is visualized from the hand up to the axilla. A normal transport is defined as a linear image and an abnormal transport as a dermal backflow image. The dermal backflow image is divided in three different classifications according to the severity.
Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet.
This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical).
The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a compression stocking is worn, a garment compression class 2, flat knitted
Time frame: up to 36 months
defined as 5% volume increase compared to the contralateral side
Time frame: up to 36 months
measured by lymphofluoroscopy
Time frame: up to 36 months
measured by the BIS
Time frame: up to 36 months
measured by Mc Gill questionnaire
Time frame: up to 36 months
measured by the pitting test at each visit
Time frame: up to 36 months
measured with moisture meter
Time frame: up to 36 months
measured by skinfold
Time frame: up to 36 months
relative volume difference at assessment - relative volume difference at baseline
Time frame: up to 36 months
scoring dermal backflow in the 13 regions
Time frame: up to 36 months
measured by lymph ICF questionnaire
Universitaire Ziekenhuizen KU Leuven
Other
Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema
Acronym: DEARLY
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